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Quality Assurance Manager

Derby

6-month contract

SRG are recruiting for a QA manager to oversee the QA activities of a leading provider of analytical services to the pharmaceutical industry. This will a contract position with an initial period of 6 month with a view to become longer term / permanent.

As the QA Manager, you will be leading the QA team to manage day to day QMS activities, ensuring quality & compliance and lead validation & improvement projects.

The Role:

As a QA Manager, you will:

• Manage all Quality Assurance activities & the pharmaceutical Quality system.
• Ensure the cGMP, cGLP & data integrity standards are maintained and quality targets / KPI’s are effectively monitored and achieved.
• Lead internal & regulatory audits and manage customer audits.
• Provide oversight of method validations/method transfers and method improvements
• Drive continuous improvement throughout the site & ensure the staff have up to date training in best quality practises.

Required:

• A degree or similar qualification in a relevant scientific field.
• Proven experience in a similar, Senior QA position within GMP / GLP environment.
• Proven leadership experience, with the ability to effectively manage, motivate and develop a team.
• Good communication skills with the ability to effectively report & communicate technical data to clients.

SRG are the UK number 1 recruitment company specialising in the science, engineering, clinical, pharmaceutical, food/FMCG, renewable, biotech, chemicals and medical devices sectors.

As scientists ourselves, our specialist sector knowledge and our passion are second to none. It’s this combination that makes us different. We’re committed to providing outstanding temporary, contract and permanent career opportunities of all levels for our candidates and a comprehensive range of expert strategic recruitment services for our clients.

If you have a scientific background and this position is not relevant / suitable for you, please feel free to get in touch or visit to view our other vacancies

• Develop, implement, and maintain quality assurance systems and procedures.
• Conduct internal and external audits to ensure compliance with standards.
• Analyse quality data and identify trends to drive process improvements.
• Investigate non-conformances and implement effective corrective actions.
• Ensure adherence to aerospace industry regulations (e.g., AS9100).
• Collaborate with engineering and manufacturing teams on quality matters.
• Prepare and maintain quality documentation and reports.
• Support product development and NPI processes from a quality perspective.
• Promote a culture of quality awareness throughout the organisation.

• Bachelor's degree in Engineering, Quality Management, or a related field.
• Proven experience in Quality Assurance within the aerospace industry.
• In-depth knowledge of AS9100 standards and quality management principles.
• Proficiency in statistical analysis and problem-solving tools.
• Strong analytical and reporting skills.
• Excellent communication and interpersonal abilities.
• Experience with Lean Manufacturing or Six Sigma methodologies is a plus.

• Develop, implement, and manage comprehensive quality assurance strategies and programs.
• Oversee the review and approval of critical documentation, including SOPs, batch records, validation protocols, and deviation reports.
• Conduct internal audits and manage external regulatory inspections, ensuring readiness and compliance.
• Lead and participate in cross-functional teams to address quality issues, implement CAPAs, and drive continuous improvement initiatives.
• Provide expert guidance on GxP regulations and quality best practices to R&D, manufacturing, and other relevant departments.
• Manage and mentor a team of QA professionals, fostering a culture of quality excellence.
• Develop and deliver GxP training programs for relevant personnel.
• Analyze quality data, identify trends, and report on key quality metrics to senior management.
• Stay updated on evolving regulatory landscapes and ensure the company's quality systems remain current and compliant.
• Lead supplier quality management activities, including audits and assessments.
• Contribute to the development and lifecycle management of pharmaceutical products.

• Master's degree or Ph.D. in Pharmacy, Chemistry, Biology, or a related life science discipline.
• A minimum of 8 years of progressive experience in pharmaceutical quality assurance and regulatory affairs.
• In-depth knowledge of cGMP, ICH guidelines, and other relevant global regulatory requirements.
• Proven experience in managing audits (internal and external) and regulatory inspections.
• Strong understanding of pharmaceutical manufacturing processes, quality control, and quality systems.
• Excellent leadership, communication, and interpersonal skills, with the ability to influence stakeholders at all levels.
• Demonstrated experience in developing and implementing robust quality management systems.
• Proficiency in root cause analysis and CAPA development and implementation.
• Experience in managing direct reports or leading QA teams.
• Ability to work independently and manage multiple priorities effectively in a remote setting.
• Strong analytical and problem-solving capabilities.
• Professional certifications such as ASQ Certified Quality Auditor (CQA) are a plus.

• Develop, implement, and manage the company's Quality Management System (QMS) in compliance with cGMP, ICH, and other relevant regulatory guidelines.
• Oversee all aspects of quality assurance for pharmaceutical products, including raw materials, in-process materials, and finished goods.
• Lead and manage the QA team, providing guidance, training, and performance management.
• Conduct internal and external audits to assess compliance and identify areas for improvement.
• Review and approve critical quality documents, including batch records, validation protocols, and change controls.
• Manage deviations, CAPAs (Corrective and Preventive Actions), and OOS (Out-of-Specification) investigations.
• Ensure all pharmaceutical manufacturing processes, equipment, and facilities meet regulatory standards.
• Liaise with regulatory authorities during inspections and respond to regulatory inquiries.
• Collaborate with R&D, manufacturing, and other departments to ensure quality is integrated throughout the product lifecycle.
• Stay current with evolving regulatory requirements and industry best practices in pharmaceutical quality assurance.
• Drive continuous improvement initiatives within the QA function and the broader organization.
• Prepare and present quality metrics and reports to senior management.

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
• Minimum of 8-10 years of progressive experience in Quality Assurance within the pharmaceutical industry.
• In-depth knowledge of cGMP regulations (FDA, EMA) and relevant international guidelines (ICH).
• Proven experience in developing and implementing QMS.
• Strong understanding of pharmaceutical development, manufacturing, and quality control processes.
• Experience in conducting and managing regulatory audits.
• Excellent leadership, team management, and interpersonal skills.
• Strong analytical, problem-solving, and decision-making abilities.
• Exceptional written and verbal communication skills, with the ability to effectively communicate complex quality issues.
• Proficiency in using quality management software and tools.
• Ability to work independently and manage multiple projects in a remote setting.

• Lead and manage the Quality Assurance department, ensuring compliance with GMP, ICH, and other relevant regulatory standards.
• Develop, implement, and maintain the company’s Quality Management System (QMS).
• Oversee the review and approval of batch records, validation protocols, and technical reports.
• Manage the deviation and CAPA (Corrective and Preventive Action) systems, ensuring timely investigation and resolution.
• Plan and conduct internal and external audits, including supplier qualification audits.
• Liaise with regulatory authorities during inspections and submissions.
• Provide QA support to manufacturing, R&D, and other departments, fostering a quality-focused culture.
• Drive continuous improvement initiatives to enhance product quality and process efficiency.
• Manage change control processes effectively.
• Train and mentor QA personnel, promoting professional development and adherence to quality standards.

• Degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• Minimum of 7 years of experience in Pharmaceutical Quality Assurance, with at least 2 years in a managerial or senior leadership role.
• In-depth knowledge of GMP, regulatory guidelines (e.g., MHRA, FDA), and quality systems.
• Proven experience in managing audits, deviations, CAPAs, and change control.
• Excellent understanding of pharmaceutical manufacturing processes and validation.
• Strong leadership, team management, and interpersonal skills.
• Exceptional analytical, problem-solving, and decision-making abilities.
• Proficiency in quality management software and tools.
• Excellent written and verbal communication skills, with the ability to present complex information clearly.
• Experience in hybrid working environments is beneficial.

• Develop, implement, and maintain the pharmaceutical Quality Management System (QMS).
• Ensure compliance with GxP regulations and relevant global regulatory standards.
• Lead and conduct internal and external quality audits.
• Manage deviations, OOS investigations, CAPAs, and change control processes.
• Review and approve critical quality-related documentation.
• Conduct risk assessments and implement quality improvement initiatives.
• Provide quality oversight for pharmaceutical development and manufacturing processes.
• Train and mentor junior QA personnel.

• BSc/MSc in Pharmacy, Chemistry, Biology, or a related life science discipline.
• Extensive experience in pharmaceutical quality assurance and regulatory compliance.
• In-depth knowledge of GxP, ICH guidelines, and regulatory expectations.
• Proven experience in auditing, deviation management, and CAPA implementation.
• Strong leadership, analytical, and problem-solving skills.
• Excellent communication and interpersonal abilities.
• Experience with hybrid work environments and effective remote collaboration tools.

• Overseeing the development, implementation, and maintenance of the Quality Management System (QMS).
• Ensuring compliance with GMP, GDP, and other relevant pharmaceutical regulations.
• Managing and mentoring a team of Quality Assurance professionals.
• Conducting internal audits and supporting external regulatory inspections.
• Investigating deviations, out-of-specifications (OOS), and out-of-trend (OOT) results.
• Developing and implementing Corrective and Preventive Actions (CAPAs).
• Providing quality oversight for change control, validation, and qualification activities.
• Reviewing and approving batch records, specifications, and other quality-critical documents.
• Assessing and managing quality risks throughout the product lifecycle.
• Collaborating with R&D, manufacturing, and regulatory affairs departments.

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Extensive experience in Pharmaceutical Quality Assurance, with a strong focus on GMP.
• Proven leadership experience in managing QA teams.
• In-depth knowledge of regulatory requirements (MHRA, FDA, EMA, ICH).
• Experience with GxP compliance, audits, and inspections.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent communication, interpersonal, and report-writing skills.
• Ability to work effectively in a hybrid work environment.

• Implement and maintain robust Quality Management Systems (QMS) in compliance with cGMP and other relevant regulatory standards (e.g., FDA, EMA).
• Conduct internal and external audits of manufacturing processes, suppliers, and quality control laboratories.
• Review and approve batch records, validation protocols, and reports.
• Manage deviations, investigations, and CAPA (Corrective and Preventive Actions) processes.
• Participate in regulatory inspections and prepare responses to regulatory queries.
• Develop and deliver quality-related training to personnel.
• Assess and approve changes to manufacturing processes, equipment, and materials through the change control system.
• Monitor and analyse quality metrics to identify trends and drive continuous improvement initiatives.
• Collaborate with cross-functional teams, including R&D, Production, and QC, to ensure quality objectives are met.
• Stay current with evolving regulatory landscapes and industry best practices.

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• Minimum of 5-7 years of experience in Pharmaceutical Quality Assurance or Quality Control.
• In-depth knowledge of cGMP, ICH guidelines, and regulatory submission processes.
• Experience with GxP environments and documentation.
• Strong understanding of pharmaceutical manufacturing processes.
• Excellent analytical, problem-solving, and decision-making skills.
• Proficiency in quality management software and MS Office Suite.
• Strong written and verbal communication skills, with meticulous attention to detail.
• Ability to work independently and as part of a collaborative team.

• Lead and manage the Quality Assurance department, ensuring compliance with GMP and other relevant regulations.
• Oversee the review and approval of batch manufacturing records, specifications, and validation protocols.
• Manage the deviation, Out-of-Specification (OOS), and CAPA systems, ensuring timely and effective resolution.
• Lead and participate in internal and external audits, including regulatory inspections and supplier audits.
• Develop, implement, and maintain the company's Quality Management System.
• Manage the change control process, ensuring all changes are assessed for their impact on product quality.
• Train and mentor QA staff, fostering professional development and high performance.
• Collaborate with cross-functional departments to address quality issues and implement improvements.
• Stay up-to-date with evolving regulatory requirements and industry best practices.
• Contribute to the strategic direction of the company's quality function.

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
• Minimum of 8 years of progressive experience in Quality Assurance within the pharmaceutical industry.
• In-depth knowledge of GMP regulations and guidelines (e.g., ICH, FDA 21 CFR Parts 210/211, EudraLex Volume 4).
• Proven experience in managing quality systems, including batch record review, deviation management, CAPA, and change control.
• Strong leadership and team management skills.
• Excellent analytical, problem-solving, and decision-making abilities.
• Exceptional communication, interpersonal, and presentation skills.
• Experience interacting with regulatory agencies during inspections.
• Proficiency in quality risk management principles.
• Experience with sterile manufacturing or biologics is a significant advantage.