Explore exciting opportunities in the realm of 146 Gcp jobs in the United Kingdom
Director, GCP Audits
Uxbridge, London
Gilead Sciences, Inc.
Posted 11 days ago
Job Viewed
Job Description
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
Job Description
At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth, and retention of talent, and empower teams to align and achieve goals.
**Director, GCP Audits**
Location: Cambridge or Stockley Park, UK
The Director, Good Clinical Practice (GCP) Audits serves a pivotal role within Gilead's R&D Quality Organization, serving as the primary point of contact for assigned R&D groups across designated geographic regions and therapeutic areas. This position is responsible for executing internal and investigator site GCP audits, in support of the R&D Quality Annual Audit plan.
This position requires close collaboration with cross-functional stakeholders, including R&D Clinical Quality Business Partners (CQBPs), the Quality Governance, Risk, Audit & Analytics (GRA&A) team, and other relevant departments. The Director is instrumental in proactively identifying, evaluating, and mitigating clinical compliance risks while supporting the overall compliance of clinical processes and portfolio. In partnership with GVP and E-System/Digital Audit groups, this role helps shape, communicate, and implement the R&D Quality Annual Audit Program.
Reporting to the Head of GCP/GLP Audits, the Director contributes to the strategic development and operational execution of the GCP audit function. Responsibilities include developing audit tools and procedures, resource planning, ensuring the effectiveness of corrective and preventive actions (CAPAs), and providing updates through quality forums and internal communications regarding audit outcomes and CAPA status.
Beyond auditing, the Director supports regulatory inspections, readiness, and partners with the R&D Quality Extended Leadership team with responsibilities for helping build and shape quality capabilities, enhance process improvements and transparency. This role is vital to maintaining global compliance, reinforcing audit excellence, and ensuring the consistent delivery of high-quality audits, supporting Gilead's mission to advance transformative therapies.
**PRIMARY RESPONSIBILITIES**
_GCP Audit Program Leadership_
+ Accountable for the successful oversight and completion of a broad spectrum of GCP audit activities and deliverables across large sites, countries, or multiple regions.
+ Lead internal and external R&D quality audits for assigned R&D groups or locations.
+ Provide matrix management and leadership to project teams.
+ Develop and drive continuous improvements in R&D quality processes, systems, and standards to meet regulatory requirements and organizational goals and contribute to the overall quality mindset and culture.
_GCP Audit Operations_
+ Act as a primary point-of-contact to assigned R&D groups and advise on: GCP regulatory requirements; relevant Gilead policies and procedures supporting audits and clinical activities.
+ Evaluate SOPs, other procedures, data and reporting of assigned R&D groups / locations to ensure ongoing regulatory compliance, R&D quality and fit-for-purpose to both Gilead business needs and regulatory requirements.
+ Execute the strategic audit plan. Plan, schedule, and conduct GCP audits in accordance with the audit plan.
+ Prepare and deliver high quality audit reports and follow up on CAPAs to ensure timely resolution and CAPA effectiveness.
+ Lead/Support risk assessment activities, in partnership with risk program and SMEs.
+ Support the overall inspection readiness of the GCP Audit program, including preparation and participation for inspections.
+ Oversee and manage the work of contractor auditors, ensuring effective oversight and completion of assigned tasks.
+ Track resources and ensure compliance with regulatory timelines and quality standards for audit deliverables.
+ Provide accurate and thorough input and recommendations into resource allocation and budgets.
_Quality Management_
+ Evaluate, and advise on systems, processes, documentation, and CAPAs for assigned R&D groups to ensure ongoing compliance and alignment with regulatory requirements.
+ Play a key role in preparing the assigned R&D groups for inspections or external reviews including ensuring alignment with Gilead business needs and regulatory requirements.
+ Support Head of GCP/GLP Audits to implement an Effectiveness Check strategy, in partnership with GVP and E-system/Digital Audit Heads for Audit related CAPAs.
+ Stay current with evolving global clinical regulations and guidance.
+ Support the development of GCP Audit material/insights for quality forums and management reviews.
_Training & Development_
+ Develop and deliver on GCP training for assigned R&D groups ensuring teams are equipped with the knowledge and skills to maintain compliance and audit excellence.
+ Establish relationships with key stakeholders, including contract auditors, cross-functional leaders, and regulatory teams to facilitate training, knowledge sharing and continuous improvement initiatives.
**BASIC QUALIFICATION:**
**Education & Experience**
+ PharmD/PhD w relevant experience
+ MA/MS/MBA with relevant experience
+ BA/BS with relevant experience or advanced degree in life sciences/related fields with significant experience in quality compliance or related fields.
+ Proficiency in clinical regulatory requirements (Global) is a must.
+ Expert-level experience working with GCP processes and systems is required.
+ Proficient in GxP Auditing with a successful track record of leading clinical/investigator site audits.
+ Broad experience participating in cross-functional projects and teams with responsibilities related to pharmacovigilance and quality system activities.
+ Significant experience leading quality, compliance or related projects in the biopharma or related industry, including leading continuous improvements such as new or updated business processes, systems and/or SOPs.
+ Significant experience advising business functions in the biopharma industry on quality and compliance requirements, evolving regulations, risk minimization and mitigation.
+ Experience working with total quality management methodologies, such as Lean Six Sigma, is preferred.
+ Certification as a Quality Auditor is preferred.
**Rest of World Education & Experience**
BA/BS or advanced degree in life sciences or related field with significant relevant experience in the biopharma industry, including significant relevant experience working in quality, compliance, pharmacovigilance, or a related field.Extensive experience leading GCP audits, in the biopharma or related industry.
**Knowledge & Other Requirements**
+ Expert knowledge of the drug development process and GCP, including global regulations (FDA, EMA, ICH) and their application to cross-functional clinical development.
+ Proficient in GxP Auditing with a successful track record of leading clinical/investigator site audits.
+ Thorough knowledge of standards, systems, policies, and procedures that enable QMS operations and compliance within the biopharma industry, specifically those related to GCP.
+ Proven effectiveness in making appropriate decisions independently for relatively complex projects or related issues, as evidenced by past decision-making track record.
+ Proven abilities to assume increasing scope and complexity, as evidenced by past successes with team and project leadership, strategic cross-functional partnering, and key contributions to strategy, operational and infrastructure development.
+ Advanced business knowledge and analytical skills, as evidenced by strengths in assessing complex information and understanding the quality and compliance implications on the portfolio.
+ Track record of successful interaction and collaboration with other functions and with senior leadership, on key projects and deliveries supporting quality and compliance.
+ Demonstrates ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of the function.
+ Demonstrates ability to integrate varied concepts and data to develop relevant solutions.
+ Proven abilities to anticipate problems of varying complexity and lead the resolution of these in a collaborative manner, across functions.
+ Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
+ Strong critical and strategic thinking skill and risk-based mindset.
+ Proven track record of successful change management implementation across highly matrixed organizations.
+ Ability to travel (up to 20%)
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
**ABOUT R&D QUALITY**
Gilead R&D Quality is a phenomenal place to develop your skills and expertise. Our strong pipeline of therapies will provide you opportunities to be challenged and stretched while supported and developed by our diverse and expert team. We are a committed team of highly skilled Quality professionals dedicated to helping deliver life-saving therapies for unmet needs. We bring our passion for science, discovery, and creative thinking into everything we do.
We are an inclusive and diverse community, who are supported by strong leaders that are committed to giving each of us a voice while achieving our mission. Our collaborative and supportive structure will help you develop your skills, experience, and your career. Are you ready to explore how you can play a vital role on the team and help deliver life-saving therapies to patients around the world?
**ABOUT GILEAD**
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
**Equal Employment Opportunity (EEO)**
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
Job Description
At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth, and retention of talent, and empower teams to align and achieve goals.
**Director, GCP Audits**
Location: Cambridge or Stockley Park, UK
The Director, Good Clinical Practice (GCP) Audits serves a pivotal role within Gilead's R&D Quality Organization, serving as the primary point of contact for assigned R&D groups across designated geographic regions and therapeutic areas. This position is responsible for executing internal and investigator site GCP audits, in support of the R&D Quality Annual Audit plan.
This position requires close collaboration with cross-functional stakeholders, including R&D Clinical Quality Business Partners (CQBPs), the Quality Governance, Risk, Audit & Analytics (GRA&A) team, and other relevant departments. The Director is instrumental in proactively identifying, evaluating, and mitigating clinical compliance risks while supporting the overall compliance of clinical processes and portfolio. In partnership with GVP and E-System/Digital Audit groups, this role helps shape, communicate, and implement the R&D Quality Annual Audit Program.
Reporting to the Head of GCP/GLP Audits, the Director contributes to the strategic development and operational execution of the GCP audit function. Responsibilities include developing audit tools and procedures, resource planning, ensuring the effectiveness of corrective and preventive actions (CAPAs), and providing updates through quality forums and internal communications regarding audit outcomes and CAPA status.
Beyond auditing, the Director supports regulatory inspections, readiness, and partners with the R&D Quality Extended Leadership team with responsibilities for helping build and shape quality capabilities, enhance process improvements and transparency. This role is vital to maintaining global compliance, reinforcing audit excellence, and ensuring the consistent delivery of high-quality audits, supporting Gilead's mission to advance transformative therapies.
**PRIMARY RESPONSIBILITIES**
_GCP Audit Program Leadership_
+ Accountable for the successful oversight and completion of a broad spectrum of GCP audit activities and deliverables across large sites, countries, or multiple regions.
+ Lead internal and external R&D quality audits for assigned R&D groups or locations.
+ Provide matrix management and leadership to project teams.
+ Develop and drive continuous improvements in R&D quality processes, systems, and standards to meet regulatory requirements and organizational goals and contribute to the overall quality mindset and culture.
_GCP Audit Operations_
+ Act as a primary point-of-contact to assigned R&D groups and advise on: GCP regulatory requirements; relevant Gilead policies and procedures supporting audits and clinical activities.
+ Evaluate SOPs, other procedures, data and reporting of assigned R&D groups / locations to ensure ongoing regulatory compliance, R&D quality and fit-for-purpose to both Gilead business needs and regulatory requirements.
+ Execute the strategic audit plan. Plan, schedule, and conduct GCP audits in accordance with the audit plan.
+ Prepare and deliver high quality audit reports and follow up on CAPAs to ensure timely resolution and CAPA effectiveness.
+ Lead/Support risk assessment activities, in partnership with risk program and SMEs.
+ Support the overall inspection readiness of the GCP Audit program, including preparation and participation for inspections.
+ Oversee and manage the work of contractor auditors, ensuring effective oversight and completion of assigned tasks.
+ Track resources and ensure compliance with regulatory timelines and quality standards for audit deliverables.
+ Provide accurate and thorough input and recommendations into resource allocation and budgets.
_Quality Management_
+ Evaluate, and advise on systems, processes, documentation, and CAPAs for assigned R&D groups to ensure ongoing compliance and alignment with regulatory requirements.
+ Play a key role in preparing the assigned R&D groups for inspections or external reviews including ensuring alignment with Gilead business needs and regulatory requirements.
+ Support Head of GCP/GLP Audits to implement an Effectiveness Check strategy, in partnership with GVP and E-system/Digital Audit Heads for Audit related CAPAs.
+ Stay current with evolving global clinical regulations and guidance.
+ Support the development of GCP Audit material/insights for quality forums and management reviews.
_Training & Development_
+ Develop and deliver on GCP training for assigned R&D groups ensuring teams are equipped with the knowledge and skills to maintain compliance and audit excellence.
+ Establish relationships with key stakeholders, including contract auditors, cross-functional leaders, and regulatory teams to facilitate training, knowledge sharing and continuous improvement initiatives.
**BASIC QUALIFICATION:**
**Education & Experience**
+ PharmD/PhD w relevant experience
+ MA/MS/MBA with relevant experience
+ BA/BS with relevant experience or advanced degree in life sciences/related fields with significant experience in quality compliance or related fields.
+ Proficiency in clinical regulatory requirements (Global) is a must.
+ Expert-level experience working with GCP processes and systems is required.
+ Proficient in GxP Auditing with a successful track record of leading clinical/investigator site audits.
+ Broad experience participating in cross-functional projects and teams with responsibilities related to pharmacovigilance and quality system activities.
+ Significant experience leading quality, compliance or related projects in the biopharma or related industry, including leading continuous improvements such as new or updated business processes, systems and/or SOPs.
+ Significant experience advising business functions in the biopharma industry on quality and compliance requirements, evolving regulations, risk minimization and mitigation.
+ Experience working with total quality management methodologies, such as Lean Six Sigma, is preferred.
+ Certification as a Quality Auditor is preferred.
**Rest of World Education & Experience**
BA/BS or advanced degree in life sciences or related field with significant relevant experience in the biopharma industry, including significant relevant experience working in quality, compliance, pharmacovigilance, or a related field.Extensive experience leading GCP audits, in the biopharma or related industry.
**Knowledge & Other Requirements**
+ Expert knowledge of the drug development process and GCP, including global regulations (FDA, EMA, ICH) and their application to cross-functional clinical development.
+ Proficient in GxP Auditing with a successful track record of leading clinical/investigator site audits.
+ Thorough knowledge of standards, systems, policies, and procedures that enable QMS operations and compliance within the biopharma industry, specifically those related to GCP.
+ Proven effectiveness in making appropriate decisions independently for relatively complex projects or related issues, as evidenced by past decision-making track record.
+ Proven abilities to assume increasing scope and complexity, as evidenced by past successes with team and project leadership, strategic cross-functional partnering, and key contributions to strategy, operational and infrastructure development.
+ Advanced business knowledge and analytical skills, as evidenced by strengths in assessing complex information and understanding the quality and compliance implications on the portfolio.
+ Track record of successful interaction and collaboration with other functions and with senior leadership, on key projects and deliveries supporting quality and compliance.
+ Demonstrates ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of the function.
+ Demonstrates ability to integrate varied concepts and data to develop relevant solutions.
+ Proven abilities to anticipate problems of varying complexity and lead the resolution of these in a collaborative manner, across functions.
+ Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
+ Strong critical and strategic thinking skill and risk-based mindset.
+ Proven track record of successful change management implementation across highly matrixed organizations.
+ Ability to travel (up to 20%)
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
**ABOUT R&D QUALITY**
Gilead R&D Quality is a phenomenal place to develop your skills and expertise. Our strong pipeline of therapies will provide you opportunities to be challenged and stretched while supported and developed by our diverse and expert team. We are a committed team of highly skilled Quality professionals dedicated to helping deliver life-saving therapies for unmet needs. We bring our passion for science, discovery, and creative thinking into everything we do.
We are an inclusive and diverse community, who are supported by strong leaders that are committed to giving each of us a voice while achieving our mission. Our collaborative and supportive structure will help you develop your skills, experience, and your career. Are you ready to explore how you can play a vital role on the team and help deliver life-saving therapies to patients around the world?
**ABOUT GILEAD**
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
**Equal Employment Opportunity (EEO)**
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
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Director, GCP Audits
Cambridge, Eastern
Gilead Sciences, Inc.
Posted 11 days ago
Job Viewed
Job Description
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
Job Description
At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth, and retention of talent, and empower teams to align and achieve goals.
**Director, GCP Audits**
Location: Cambridge or Stockley Park, UK
The Director, Good Clinical Practice (GCP) Audits serves a pivotal role within Gilead's R&D Quality Organization, serving as the primary point of contact for assigned R&D groups across designated geographic regions and therapeutic areas. This position is responsible for executing internal and investigator site GCP audits, in support of the R&D Quality Annual Audit plan.
This position requires close collaboration with cross-functional stakeholders, including R&D Clinical Quality Business Partners (CQBPs), the Quality Governance, Risk, Audit & Analytics (GRA&A) team, and other relevant departments. The Director is instrumental in proactively identifying, evaluating, and mitigating clinical compliance risks while supporting the overall compliance of clinical processes and portfolio. In partnership with GVP and E-System/Digital Audit groups, this role helps shape, communicate, and implement the R&D Quality Annual Audit Program.
Reporting to the Head of GCP/GLP Audits, the Director contributes to the strategic development and operational execution of the GCP audit function. Responsibilities include developing audit tools and procedures, resource planning, ensuring the effectiveness of corrective and preventive actions (CAPAs), and providing updates through quality forums and internal communications regarding audit outcomes and CAPA status.
Beyond auditing, the Director supports regulatory inspections, readiness, and partners with the R&D Quality Extended Leadership team with responsibilities for helping build and shape quality capabilities, enhance process improvements and transparency. This role is vital to maintaining global compliance, reinforcing audit excellence, and ensuring the consistent delivery of high-quality audits, supporting Gilead's mission to advance transformative therapies.
**PRIMARY RESPONSIBILITIES**
_GCP Audit Program Leadership_
+ Accountable for the successful oversight and completion of a broad spectrum of GCP audit activities and deliverables across large sites, countries, or multiple regions.
+ Lead internal and external R&D quality audits for assigned R&D groups or locations.
+ Provide matrix management and leadership to project teams.
+ Develop and drive continuous improvements in R&D quality processes, systems, and standards to meet regulatory requirements and organizational goals and contribute to the overall quality mindset and culture.
_GCP Audit Operations_
+ Act as a primary point-of-contact to assigned R&D groups and advise on: GCP regulatory requirements; relevant Gilead policies and procedures supporting audits and clinical activities.
+ Evaluate SOPs, other procedures, data and reporting of assigned R&D groups / locations to ensure ongoing regulatory compliance, R&D quality and fit-for-purpose to both Gilead business needs and regulatory requirements.
+ Execute the strategic audit plan. Plan, schedule, and conduct GCP audits in accordance with the audit plan.
+ Prepare and deliver high quality audit reports and follow up on CAPAs to ensure timely resolution and CAPA effectiveness.
+ Lead/Support risk assessment activities, in partnership with risk program and SMEs.
+ Support the overall inspection readiness of the GCP Audit program, including preparation and participation for inspections.
+ Oversee and manage the work of contractor auditors, ensuring effective oversight and completion of assigned tasks.
+ Track resources and ensure compliance with regulatory timelines and quality standards for audit deliverables.
+ Provide accurate and thorough input and recommendations into resource allocation and budgets.
_Quality Management_
+ Evaluate, and advise on systems, processes, documentation, and CAPAs for assigned R&D groups to ensure ongoing compliance and alignment with regulatory requirements.
+ Play a key role in preparing the assigned R&D groups for inspections or external reviews including ensuring alignment with Gilead business needs and regulatory requirements.
+ Support Head of GCP/GLP Audits to implement an Effectiveness Check strategy, in partnership with GVP and E-system/Digital Audit Heads for Audit related CAPAs.
+ Stay current with evolving global clinical regulations and guidance.
+ Support the development of GCP Audit material/insights for quality forums and management reviews.
_Training & Development_
+ Develop and deliver on GCP training for assigned R&D groups ensuring teams are equipped with the knowledge and skills to maintain compliance and audit excellence.
+ Establish relationships with key stakeholders, including contract auditors, cross-functional leaders, and regulatory teams to facilitate training, knowledge sharing and continuous improvement initiatives.
**BASIC QUALIFICATION:**
**Education & Experience**
+ PharmD/PhD w relevant experience
+ MA/MS/MBA with relevant experience
+ BA/BS with relevant experience or advanced degree in life sciences/related fields with significant experience in quality compliance or related fields.
+ Proficiency in clinical regulatory requirements (Global) is a must.
+ Expert-level experience working with GCP processes and systems is required.
+ Proficient in GxP Auditing with a successful track record of leading clinical/investigator site audits.
+ Broad experience participating in cross-functional projects and teams with responsibilities related to pharmacovigilance and quality system activities.
+ Significant experience leading quality, compliance or related projects in the biopharma or related industry, including leading continuous improvements such as new or updated business processes, systems and/or SOPs.
+ Significant experience advising business functions in the biopharma industry on quality and compliance requirements, evolving regulations, risk minimization and mitigation.
+ Experience working with total quality management methodologies, such as Lean Six Sigma, is preferred.
+ Certification as a Quality Auditor is preferred.
**Rest of World Education & Experience**
BA/BS or advanced degree in life sciences or related field with significant relevant experience in the biopharma industry, including significant relevant experience working in quality, compliance, pharmacovigilance, or a related field.Extensive experience leading GCP audits, in the biopharma or related industry.
**Knowledge & Other Requirements**
+ Expert knowledge of the drug development process and GCP, including global regulations (FDA, EMA, ICH) and their application to cross-functional clinical development.
+ Proficient in GxP Auditing with a successful track record of leading clinical/investigator site audits.
+ Thorough knowledge of standards, systems, policies, and procedures that enable QMS operations and compliance within the biopharma industry, specifically those related to GCP.
+ Proven effectiveness in making appropriate decisions independently for relatively complex projects or related issues, as evidenced by past decision-making track record.
+ Proven abilities to assume increasing scope and complexity, as evidenced by past successes with team and project leadership, strategic cross-functional partnering, and key contributions to strategy, operational and infrastructure development.
+ Advanced business knowledge and analytical skills, as evidenced by strengths in assessing complex information and understanding the quality and compliance implications on the portfolio.
+ Track record of successful interaction and collaboration with other functions and with senior leadership, on key projects and deliveries supporting quality and compliance.
+ Demonstrates ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of the function.
+ Demonstrates ability to integrate varied concepts and data to develop relevant solutions.
+ Proven abilities to anticipate problems of varying complexity and lead the resolution of these in a collaborative manner, across functions.
+ Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
+ Strong critical and strategic thinking skill and risk-based mindset.
+ Proven track record of successful change management implementation across highly matrixed organizations.
+ Ability to travel (up to 20%)
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
**ABOUT R&D QUALITY**
Gilead R&D Quality is a phenomenal place to develop your skills and expertise. Our strong pipeline of therapies will provide you opportunities to be challenged and stretched while supported and developed by our diverse and expert team. We are a committed team of highly skilled Quality professionals dedicated to helping deliver life-saving therapies for unmet needs. We bring our passion for science, discovery, and creative thinking into everything we do.
We are an inclusive and diverse community, who are supported by strong leaders that are committed to giving each of us a voice while achieving our mission. Our collaborative and supportive structure will help you develop your skills, experience, and your career. Are you ready to explore how you can play a vital role on the team and help deliver life-saving therapies to patients around the world?
**ABOUT GILEAD**
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
**Equal Employment Opportunity (EEO)**
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
Job Description
At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth, and retention of talent, and empower teams to align and achieve goals.
**Director, GCP Audits**
Location: Cambridge or Stockley Park, UK
The Director, Good Clinical Practice (GCP) Audits serves a pivotal role within Gilead's R&D Quality Organization, serving as the primary point of contact for assigned R&D groups across designated geographic regions and therapeutic areas. This position is responsible for executing internal and investigator site GCP audits, in support of the R&D Quality Annual Audit plan.
This position requires close collaboration with cross-functional stakeholders, including R&D Clinical Quality Business Partners (CQBPs), the Quality Governance, Risk, Audit & Analytics (GRA&A) team, and other relevant departments. The Director is instrumental in proactively identifying, evaluating, and mitigating clinical compliance risks while supporting the overall compliance of clinical processes and portfolio. In partnership with GVP and E-System/Digital Audit groups, this role helps shape, communicate, and implement the R&D Quality Annual Audit Program.
Reporting to the Head of GCP/GLP Audits, the Director contributes to the strategic development and operational execution of the GCP audit function. Responsibilities include developing audit tools and procedures, resource planning, ensuring the effectiveness of corrective and preventive actions (CAPAs), and providing updates through quality forums and internal communications regarding audit outcomes and CAPA status.
Beyond auditing, the Director supports regulatory inspections, readiness, and partners with the R&D Quality Extended Leadership team with responsibilities for helping build and shape quality capabilities, enhance process improvements and transparency. This role is vital to maintaining global compliance, reinforcing audit excellence, and ensuring the consistent delivery of high-quality audits, supporting Gilead's mission to advance transformative therapies.
**PRIMARY RESPONSIBILITIES**
_GCP Audit Program Leadership_
+ Accountable for the successful oversight and completion of a broad spectrum of GCP audit activities and deliverables across large sites, countries, or multiple regions.
+ Lead internal and external R&D quality audits for assigned R&D groups or locations.
+ Provide matrix management and leadership to project teams.
+ Develop and drive continuous improvements in R&D quality processes, systems, and standards to meet regulatory requirements and organizational goals and contribute to the overall quality mindset and culture.
_GCP Audit Operations_
+ Act as a primary point-of-contact to assigned R&D groups and advise on: GCP regulatory requirements; relevant Gilead policies and procedures supporting audits and clinical activities.
+ Evaluate SOPs, other procedures, data and reporting of assigned R&D groups / locations to ensure ongoing regulatory compliance, R&D quality and fit-for-purpose to both Gilead business needs and regulatory requirements.
+ Execute the strategic audit plan. Plan, schedule, and conduct GCP audits in accordance with the audit plan.
+ Prepare and deliver high quality audit reports and follow up on CAPAs to ensure timely resolution and CAPA effectiveness.
+ Lead/Support risk assessment activities, in partnership with risk program and SMEs.
+ Support the overall inspection readiness of the GCP Audit program, including preparation and participation for inspections.
+ Oversee and manage the work of contractor auditors, ensuring effective oversight and completion of assigned tasks.
+ Track resources and ensure compliance with regulatory timelines and quality standards for audit deliverables.
+ Provide accurate and thorough input and recommendations into resource allocation and budgets.
_Quality Management_
+ Evaluate, and advise on systems, processes, documentation, and CAPAs for assigned R&D groups to ensure ongoing compliance and alignment with regulatory requirements.
+ Play a key role in preparing the assigned R&D groups for inspections or external reviews including ensuring alignment with Gilead business needs and regulatory requirements.
+ Support Head of GCP/GLP Audits to implement an Effectiveness Check strategy, in partnership with GVP and E-system/Digital Audit Heads for Audit related CAPAs.
+ Stay current with evolving global clinical regulations and guidance.
+ Support the development of GCP Audit material/insights for quality forums and management reviews.
_Training & Development_
+ Develop and deliver on GCP training for assigned R&D groups ensuring teams are equipped with the knowledge and skills to maintain compliance and audit excellence.
+ Establish relationships with key stakeholders, including contract auditors, cross-functional leaders, and regulatory teams to facilitate training, knowledge sharing and continuous improvement initiatives.
**BASIC QUALIFICATION:**
**Education & Experience**
+ PharmD/PhD w relevant experience
+ MA/MS/MBA with relevant experience
+ BA/BS with relevant experience or advanced degree in life sciences/related fields with significant experience in quality compliance or related fields.
+ Proficiency in clinical regulatory requirements (Global) is a must.
+ Expert-level experience working with GCP processes and systems is required.
+ Proficient in GxP Auditing with a successful track record of leading clinical/investigator site audits.
+ Broad experience participating in cross-functional projects and teams with responsibilities related to pharmacovigilance and quality system activities.
+ Significant experience leading quality, compliance or related projects in the biopharma or related industry, including leading continuous improvements such as new or updated business processes, systems and/or SOPs.
+ Significant experience advising business functions in the biopharma industry on quality and compliance requirements, evolving regulations, risk minimization and mitigation.
+ Experience working with total quality management methodologies, such as Lean Six Sigma, is preferred.
+ Certification as a Quality Auditor is preferred.
**Rest of World Education & Experience**
BA/BS or advanced degree in life sciences or related field with significant relevant experience in the biopharma industry, including significant relevant experience working in quality, compliance, pharmacovigilance, or a related field.Extensive experience leading GCP audits, in the biopharma or related industry.
**Knowledge & Other Requirements**
+ Expert knowledge of the drug development process and GCP, including global regulations (FDA, EMA, ICH) and their application to cross-functional clinical development.
+ Proficient in GxP Auditing with a successful track record of leading clinical/investigator site audits.
+ Thorough knowledge of standards, systems, policies, and procedures that enable QMS operations and compliance within the biopharma industry, specifically those related to GCP.
+ Proven effectiveness in making appropriate decisions independently for relatively complex projects or related issues, as evidenced by past decision-making track record.
+ Proven abilities to assume increasing scope and complexity, as evidenced by past successes with team and project leadership, strategic cross-functional partnering, and key contributions to strategy, operational and infrastructure development.
+ Advanced business knowledge and analytical skills, as evidenced by strengths in assessing complex information and understanding the quality and compliance implications on the portfolio.
+ Track record of successful interaction and collaboration with other functions and with senior leadership, on key projects and deliveries supporting quality and compliance.
+ Demonstrates ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of the function.
+ Demonstrates ability to integrate varied concepts and data to develop relevant solutions.
+ Proven abilities to anticipate problems of varying complexity and lead the resolution of these in a collaborative manner, across functions.
+ Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
+ Strong critical and strategic thinking skill and risk-based mindset.
+ Proven track record of successful change management implementation across highly matrixed organizations.
+ Ability to travel (up to 20%)
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
**ABOUT R&D QUALITY**
Gilead R&D Quality is a phenomenal place to develop your skills and expertise. Our strong pipeline of therapies will provide you opportunities to be challenged and stretched while supported and developed by our diverse and expert team. We are a committed team of highly skilled Quality professionals dedicated to helping deliver life-saving therapies for unmet needs. We bring our passion for science, discovery, and creative thinking into everything we do.
We are an inclusive and diverse community, who are supported by strong leaders that are committed to giving each of us a voice while achieving our mission. Our collaborative and supportive structure will help you develop your skills, experience, and your career. Are you ready to explore how you can play a vital role on the team and help deliver life-saving therapies to patients around the world?
**ABOUT GILEAD**
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
**Equal Employment Opportunity (EEO)**
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
This advertiser has chosen not to accept applicants from your region.
1
Data Architect - GCP
London, London
ZipRecruiter
Posted today
Job Viewed
Job Description
Overview
A GCP Data Architect is required to join a Google partner who are helping various private sector clients migrate from an on-prem data warehouse to GCP. The GCP Data Architect is required to design data architecture patterns, evaluate different approaches and technologies, and communicate with various design working groups and architecture forums.nResponsibilities
Design data architecture patterns, evaluate different approaches and technologies, and communicate with design working groups and architecture forums.nQualifications
Extensive experience with GCP and BigQuery essential (at least 2 years experience - relevant certifications a bonus)nGood communication, stakeholder management and negotiation skills (consultative approach)nExperience with other technologies such as Hadoop, Hbase, Hive, DataProc, DataFlow and/or GKE would be usefulnAdditional Information
If interested in discussing further, please apply immediately and we'll endeavour to get in touch with successful applicants ASAP.nPlease note this role is entirely remote. The client would ideally like someone to visit their London office every few weeks but this is negotiable.nEames Consulting is acting as an Employment Business in relation to this vacancy.
#J-18808-Ljbffrn
A GCP Data Architect is required to join a Google partner who are helping various private sector clients migrate from an on-prem data warehouse to GCP. The GCP Data Architect is required to design data architecture patterns, evaluate different approaches and technologies, and communicate with various design working groups and architecture forums.nResponsibilities
Design data architecture patterns, evaluate different approaches and technologies, and communicate with design working groups and architecture forums.nQualifications
Extensive experience with GCP and BigQuery essential (at least 2 years experience - relevant certifications a bonus)nGood communication, stakeholder management and negotiation skills (consultative approach)nExperience with other technologies such as Hadoop, Hbase, Hive, DataProc, DataFlow and/or GKE would be usefulnAdditional Information
If interested in discussing further, please apply immediately and we'll endeavour to get in touch with successful applicants ASAP.nPlease note this role is entirely remote. The client would ideally like someone to visit their London office every few weeks but this is negotiable.nEames Consulting is acting as an Employment Business in relation to this vacancy.
#J-18808-Ljbffrn
This advertiser has chosen not to accept applicants from your region.
2
GCP Cloud Developer
Warwick, West Midlands
Queen Square Recruitment Limited
Posted 10 days ago
Job Viewed
Job Description
Job Title: GCP Cloud Developer
Location: Warwick, UK (Hybrid 3 days onsite)
Contract Type: 6-month Contract
Rate: £450/day (Inside IR35)
About the Role
We are looking for a highly skilled GCP Cloud Developer to design, develop, and deploy scalable cloud solutions using Google Cloud Platform . This role is ideal for someone who thrives in a fast-paced environment, enjoys working with modern serverless .
This advertiser has chosen not to accept applicants from your region.
3
Senior Consultant - GCP Data Engineer
Liverpool, North West
£50000 - £70000 annum
Intuita - Vacancies
Posted 15 days ago
Job Viewed
Job Description
This advertiser has chosen not to accept applicants from your region.
4
GCP Integration Focused Developer
Warwick, West Midlands
£380 day
Queen Square Recruitment Limited
Posted today
Job Viewed
Job Description
GCP Integration-Focused Developer
Location: Warwick, UK (Hybrid 3 days on-site per week)
Contract: 6 months rolling
Day Rate: £380 ( inside IR35)
We are seeking a skilled and detail-oriented GCP Integration-Focused Developer to join our team. You will design, build, and manage API-based integrations across Google Cloud Platform, ensuring secure, scalable, and high-performing solutions.
Key Responsibil.
This advertiser has chosen not to accept applicants from your region.
5
Associate Director, GCP Quality
Oxford, South East
Exscientia
Posted 513 days ago
Job Viewed
Job Description
About Us
Exscientia is an AI-driven pharmatech company committed to discovering, designing and developing the best possible drugs in the fastest and most effective manner. Exscientia developed the first-ever functional precision oncology platform to successfully guide treatment selection and improve patient outcomes in a prospective interventional clinical study, as well as to progress AI-designed small molecules into the clinical setting.
Our pipeline demonstrates our ability to rapidly translate scientific concepts into precision-designed therapeutic candidates, with more than 15 projects underway. By designing better drugs, faster, we believe the best ideas of science can rapidly become the best medicines for patients.
Our Quality vision is to build a quality mindset and embed Quality by Design principles across the enterprise to enable work to be done in the right way. Quality is for everyone!
Our Quality mission is to design & develop a single, fit for purpose Quality Management System (QMS) across GxP regulated areas. In addition, Quality being a trusted partner for stakeholders, with a patient & compliance focus within R&D Oncology.
The Role
We are seeking an Associate Director, GCP Quality to contribute to our company mission to develop better medicines, faster, together with our Quality mission & vision summarised above. In this role you will lead the GCP Quality support for our interventional clinical trials, serve as a GCP Quality expert to the business, and establish strong relationships with the Development & Precision Medicine functions.
Key responsibilities include:
- Providing GCP expert advice & guidance to project/study teams
- Escalation of compliance risks/issues to line management
- Quality review of GCP essential records
- Actively contribute to the Quality mission to design & develop a single, fit for purpose QMS
- Conduct GCP process, vendor, and investigator site audits.
- Support GxP Quality needs in Development & Precision functions, e.g. GVP, GLP, GDP/GMP & CSV
Please note this is a UK hybrid role and occasional travel is required to our Oxford, UK offices (approximately once a week) and Vienna, Austria offices (approximately every quarter), and for conducting global audits (approximately a week every quarter) with flexibility to work from home the remaining time. We are a flexible working organisation and we’re willing to consider other options which would provide similar contact time with the team.
You will have the opportunity to:
- Provide day to day GCP compliance support to the study teams and project deliverables, in your role as Quality Lead for interventional clinical trials
- Monitor risks and deviations/issues in Clinical Development & escalate to line management promptly. Lead investigations into significant quality issues and potential serious breaches of GCP
- Conduct quality reviews of GCP essential records as required, e.g. Investigator Brochures, Protocols, ICF/PIS, key study manuals/plans (such as lab, monitoring, communication, pharmacy, data management, and statistical), clinical study report
- Plan, prepare, conduct, report and follow up to closure on GCP related audits
- Drive Quality by Design principles and Critical to Quality factors within Clinical Development
- Active & collaborative member of the Quality team based in the UK & Austria, supporting other Quality responsibilities as required, e.g. QMS enhancements, Veeva Quality/QMS/training system maintenance, non-interventional clinical trials, clinical sample management, non-clinical/GLP studies.
Requirements
- Strong GCP Quality experience in biotech/pharma which spans clinical trial phases I to III
- Expert in GCP global regulations and guidance (e.g. ICH E6, ICH E8, EU CTR, FDA CFRs) and current GCP industry best practices. Knowledge and experience of other GxP regulations & guidance would be benefical, e.g. GVP, GLP OECD, GMP/GDP PICS, & CSV
- Demonstrates auditing experience across different types of GCP audits (e.g. CRO, phase I, investigator sites, essential records, process/system audits). Auditing, conduct/exposure in GVP, GLP (e.g. labs/CROs), CSV, and GMP/GDP would be beneficial
- Experience of participating in regulatory agency inspections, e.g. MHRA, FDA, EMA) and presenting quality metrics/analytics
- Introduce efficiencies to QMS (i.e. Policies, SOPs, Working Instructions) in line with Quality mission to develop a single, fit for purpose QMS across GxP regulated areas
- Bachelor degree in life sciences or healthcare related area.
Essential skills:
- Excellent interpersonal and verbal/written communication skills
- Highly collaborative team player who listens, encourages, contributes, challenges and improves performance/deliverables
- Takes responsibility for delivering Quality & Development projects & initiatives through cross-functional influence
- Ability to think ‘outside the box’ to identify risks/challenges and deliver creative solutions
- Global and strategic mindset
- Generally needs no or minimal instructions on day to day work.
Benefits
- Join our inclusive, collaborative and intellectually stimulating organisation with strong company values.
- As a learning organisation, we provide access to learning and development opportunities and will place you at the forefront of your career growth at Exscientia.
- We employ brilliant people so we pay highly competitive salaries. Additionally, all our employees are eligible for a company-wide annual bonus and receive both a new joiner and annual share award.
- Enjoy our generous holiday allowance and flexible working approach to find a healthy work-life balance that works for you.
- Create amazing memories or progress your personal and professional development with our four-week paid sabbatical after four years of service.
- We’re leading the way in progressive leave, offering enhanced policies such as generous parental leave, surrogacy, menopause, and family emergency leave so you feel supported no matter the life event.
- Additionally, we support childcare costs for children aged 0-5 through our affordable childcare scheme.
- Take advantage of two generous salary exchange schemes to claim discounts on a brand new electric vehicle and cycling equipment worth up to £3,500.
- As a healthcare company, we understand the importance of health and wellbeing so we provide comprehensive private health insurance, dental and vision benefits for you and your family.
- We also provide plenty of access to mental health support including therapy and counselling sessions plus an employee assistance program for help with lifestyle issues such as bereavement, family problems or money management.
- To help safeguard the future for you and your loved ones, we also offer pension and life cover.
- Help yourself to free drinks and snacks in our fully stocked kitchens. Join your colleagues in one of our many breakout areas and get to know the people you are working with. Some of the best ideas start with a coffee break!
- Feel inspired in our high spec labs where you will use state-of-the-art equipment and instrumentation that enable you to do your best work.
- We’ll even support your home office environment with an allowance for furniture and equipment to make your space as comfortable and productive as possible.
- Learn more about why our team enjoy working at Exscientia here
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6
Associate Director Inspection Management (GCP)
Uxbridge, London
Regeneron Pharmaceuticals
Posted 8 days ago
Job Viewed
Job Description
The Associate Director, Global Development Quality Inspection Management (GDQIM) acting as an Inspection Management Lead (IML) is a key position that is responsible for the effective management of GCP, GVP and GLP inspections. The GDQIM IML will engage with key stakeholders, build strategic partnerships working and liaising with Clinical Study teams, relevant functions and other GDQ functions to support teams with inspection preparation activities on all Regeneron-sponsored clinical trials.
**In this role, a typical day might include the following:**
Ensuring and managing the notification of all relevant internal and external stakeholders of upcoming and/or anticipated regulatory inspections.
- Ensuring the preparation, management and integration of inspection management processes and training activities into the clinical development programs and all relevant stakeholders.
- Providing effective guidance, consultancy, and support to the Clinical Study Teams (and any other key stakeholders) in advance of an impending inspection.
- Assisting with the identification of opportunities to conduct mock inspections and/or Investigator Site Preparation Visits, in collaboration with the GD Quality Assurance (GDQA) team and other relevant functional groups.
- Identifying and discussing with the Clinical Study Teams potential issues and/or gaps, in advance of an impending inspection, that may require strategies to mitigate risk and/or provide additional clarification to an inspector.
- Ensuring the preparation, management and conduct of inspection preparation sessions which include mock inspections, trainings, and clinical site preparation visits working with GDQA team to identify and mitigate risks to clinical programs.
- Serving as the back room lead/co-lead or front room co-lead, responsible for explaining, managing,and ensuring the execution of all activities, including managing the tracking of requests and inquiries, and coordinating requests for responses from relevant personnel during any regulatory inspection conducted worldwide.
- Responsible for managing the preparation and provision of timely inspection updates and daily/end of inspection summaries to GD Executive and Senior Management, in addition to any other key relevant internal and external stakeholders.
- Responsible for managing inspection response development, and Corrective Actions/Preventive Actions (CAPA) follow-up activities alongside other GDQIM colleagues, cross-functional stakeholders, and process owners.
- Ensuring and managing the development, collection, reporting and analysis of inspection-related quality data, trends, and metrics.
**This role may be for you if have:**
- Advanced knowledge, understanding and application of GCP, and/or GVP
guidelines including the management of significant/complex quality issues
and compliance activities.
- Extensive experience with participating in, and supporting, Regulatory
Agency Inspections of Investigator Sites, Sponsors and Clinical Research
Organizations (CROs) in a GxP environment, including inspection
preparation, facilitation, and follow-up.
- Effective management of interpersonal relationships, stakeholder
engagement, and collaborations.
- Demonstrated ability to interface and collaborate effectively with other
Managers and Directors within, and external to, the organization.
- Extensive experience in providing training and presenting information on
key quality and regulatory compliance information.
**To be considered for this opportunity we are looking for:**
Bachelor's degree with a minimum of 10 years of relevant
healthcare/pharmaceutical industry experience.
- Experience working in either a quality/compliance role (e.g., Quality
Management, Quality Assurance etc.), or in a Clinical Development role
with expertise and/or transferable skills related to Good Clinical Practice
(GCP), and/or Good Pharmacovigilance Practice (GVP).
- Experience in training, supervising, line management, mentoring and
development of staff, and leading a small team
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
**In this role, a typical day might include the following:**
Ensuring and managing the notification of all relevant internal and external stakeholders of upcoming and/or anticipated regulatory inspections.
- Ensuring the preparation, management and integration of inspection management processes and training activities into the clinical development programs and all relevant stakeholders.
- Providing effective guidance, consultancy, and support to the Clinical Study Teams (and any other key stakeholders) in advance of an impending inspection.
- Assisting with the identification of opportunities to conduct mock inspections and/or Investigator Site Preparation Visits, in collaboration with the GD Quality Assurance (GDQA) team and other relevant functional groups.
- Identifying and discussing with the Clinical Study Teams potential issues and/or gaps, in advance of an impending inspection, that may require strategies to mitigate risk and/or provide additional clarification to an inspector.
- Ensuring the preparation, management and conduct of inspection preparation sessions which include mock inspections, trainings, and clinical site preparation visits working with GDQA team to identify and mitigate risks to clinical programs.
- Serving as the back room lead/co-lead or front room co-lead, responsible for explaining, managing,and ensuring the execution of all activities, including managing the tracking of requests and inquiries, and coordinating requests for responses from relevant personnel during any regulatory inspection conducted worldwide.
- Responsible for managing the preparation and provision of timely inspection updates and daily/end of inspection summaries to GD Executive and Senior Management, in addition to any other key relevant internal and external stakeholders.
- Responsible for managing inspection response development, and Corrective Actions/Preventive Actions (CAPA) follow-up activities alongside other GDQIM colleagues, cross-functional stakeholders, and process owners.
- Ensuring and managing the development, collection, reporting and analysis of inspection-related quality data, trends, and metrics.
**This role may be for you if have:**
- Advanced knowledge, understanding and application of GCP, and/or GVP
guidelines including the management of significant/complex quality issues
and compliance activities.
- Extensive experience with participating in, and supporting, Regulatory
Agency Inspections of Investigator Sites, Sponsors and Clinical Research
Organizations (CROs) in a GxP environment, including inspection
preparation, facilitation, and follow-up.
- Effective management of interpersonal relationships, stakeholder
engagement, and collaborations.
- Demonstrated ability to interface and collaborate effectively with other
Managers and Directors within, and external to, the organization.
- Extensive experience in providing training and presenting information on
key quality and regulatory compliance information.
**To be considered for this opportunity we are looking for:**
Bachelor's degree with a minimum of 10 years of relevant
healthcare/pharmaceutical industry experience.
- Experience working in either a quality/compliance role (e.g., Quality
Management, Quality Assurance etc.), or in a Clinical Development role
with expertise and/or transferable skills related to Good Clinical Practice
(GCP), and/or Good Pharmacovigilance Practice (GVP).
- Experience in training, supervising, line management, mentoring and
development of staff, and leading a small team
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
This advertiser has chosen not to accept applicants from your region.
7
Senior Cloud Engineer AWS GCP - Fintech
EC2A 4EB
Client Server
Posted 1 day ago
Job Viewed
Job Description
Senior Cloud Engineer (AWS GCP IaaS PaaS) London / WFH to £110k
Are you a cloud technologist? You could be progressing your career in an impactful Senior Cloud Engineer role at a global FinTech / CFD trading company that has been consistently voted as one of the UKs top employers.
As a Senior Cloud Engineer you will join a small team and be instrumental in designing, implementing and maintaining clo.
WHJS1_UKTJ
This advertiser has chosen not to accept applicants from your region.
8