QARA Professional

Cambridge, Eastern TOGL (Holdings) Limited

Posted 12 days ago

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Job Description

Permanent

About Ellele Health

Ellele Health is a wholly owned subsidiary within The Origin Group Limited (TOGL). Ellele Health is a medical research company dedicated to transforming women’s health. We have developed a novel sampling medical device to support early detection and management of critical conditions like endometrial cancer.

Ellele Health is a small, innovation focused start-up, seeking candidates who are passionate about women’s health innovation and driven to create meaningful, impactful change. We foster a positive, collaborative, and supportive work culture, where every team member’s ideas are valued and everyone plays an active role in shaping our mission and success.

Role Overview

We are seeking a motivated and experienced Quality and Regulatory Affairs professional to support our ongoing commitment to excellence and regulatory compliance.  Key focus will be on maintaining and evolving our ISO 13485-compliant QMS and supporting the initial ISO certification process, as well generation and management of technical documentation and overseeing all areas of regulatory affairs.

This role offers flexibility and can be structured on a part-time basis, depending on experience of the right candidate.

Key Responsibilities

  • Maintain, evolve, and ensure compliance of the QMS to ISO 13485 and drive the preparation and successful achievement of ISO 13485 certification
  • Prepare, document, and implement policies and procedures
  • Lead and coordinate internal audits, supplier audits, management reviews, and continuous improvement initiatives
  • Ensure compliance with UK MDR and EU MDR
  • Lead all post-marketing activities in line with quality and regulatory requirements under UK MDR, EU MDR and ISO 13485
  • Act as the PRRC
  • Develop, manage, and maintain technical documentation and DHFs in accordance with EU MDR and UK MDR requirements
  • Have past experience in clinical investigations for medical devices, including preparing required documentation
  • Oversee regulatory and quality compliance during clinical investigations, ensuring proper processes, documentation, and reporting are in place
  • Manage all post-clinical investigation activities, including reporting, data handling, and updates to technical files and regulatory submissions
  • Monitor and interpret changes in relevant regulations and standards
  • Advise the leadership team on quality and regulatory implications for new and existing products
  • Serve as the primary contact for external auditors and regulatory authorities
  • Ensure training, communication, and awareness of quality and regulatory requirements across the team

Requirements

  • Proven experience working with medical devices and procedure packs. Experience in Class I medical devices under UK and European regulatory frameworks
  • Strong working knowledge of ISO 13485 with direct experience in implementation and/or maintenance
  • Ability to manage a QMS independently and confidently
  • Up-to-date understanding of both UK and European medical device regulations
  • Good working knowledge of harmonised standards, such as ISO 14971, ISO 14155, ISO 10993 and IEC 62366-1
  • Strong organisational, communication, and problem-solving skills
  • Ability to work flexibly and independently in a small, fast-paced organisation
  • To have a can-do attitude, with no task too large or too small

Nice to Have:

  • Working in a start-up environment
  • Knowledge regarding RoW and US regulations

Benefits

Join Us

  • Be part of a mission-driven group innovating in both gastrointestinal and women’s health diagnostics.
  • Unique opportunity to contribute across two pioneering clinical pipelines.
  • Collaborative, forward-thinking environment within a high-growth company.
  • Competitive salary, benefits, and opportunities for advancement.
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Remote Professional Cleaner

CB2 1AA Cambridge, Eastern £15 Hourly WhatJobs

Posted 2 days ago

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contractor
Our client is seeking highly dependable and meticulous Remote Professional Cleaners to join their expanding network of service providers. This is a contract-based, fully remote role where you will manage your own schedule and client assignments within the Cambridge area, facilitated through our digital platform. You will be responsible for delivering exceptional cleaning services to residential and potentially small commercial properties, ensuring a high standard of cleanliness, hygiene, and customer satisfaction. This role requires self-motivation, excellent time management, and a commitment to quality work.

Key responsibilities include performing a range of cleaning duties, such as dusting, vacuuming, mopping, sanitizing bathrooms and kitchens, and ensuring all areas are left immaculate. You will be expected to manage your own cleaning supplies and equipment, ensuring they are well-maintained and used safely and effectively. Adhering to specific client instructions and preferences, while upholding the company's standards for service excellence, is paramount. Efficiently scheduling and managing your cleaning appointments through our online portal is essential to maintain a consistent workflow. Maintaining clear and professional communication with clients, addressing any queries or concerns promptly, is also a vital part of the role.

The ideal candidate will have previous professional cleaning experience, with a strong understanding of cleaning techniques and the safe use of cleaning products. Reliability, trustworthiness, and a keen eye for detail are essential qualities. You must be physically fit and able to perform the demands of the job, including bending, lifting, and standing for extended periods. A valid UK driving license and access to your own reliable transportation would be advantageous for efficient client site access. A smartphone with internet access is required for managing assignments and communicating with clients via our platform. Previous experience in the hospitality or facilities management sector is a plus. This is a flexible opportunity for individuals who take pride in their work and want to build a rewarding career on their own terms, offering the freedom and flexibility of remote work.
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Director of Strategic Planning

CB2 1HW Cambridge, Eastern £80000 Annually WhatJobs

Posted 20 days ago

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full-time
Our client is seeking a highly accomplished and strategic Director of Strategic Planning to join their esteemed organization in Cambridge, Cambridgeshire, UK . This is a critical leadership role requiring a dynamic individual with a proven track record in developing and executing long-term business strategies.

Responsibilities:
  • Develop and oversee the implementation of the company's overall strategic plan, aligning with market trends and organizational goals.
  • Conduct comprehensive market research, competitive analysis, and industry benchmarking to identify growth opportunities and potential threats.
  • Collaborate with executive leadership and department heads to define strategic objectives, key performance indicators (KPIs), and actionable initiatives.
  • Lead the strategic planning process, including annual reviews, scenario planning, and long-range forecasting.
  • Analyze financial data and market intelligence to support strategic decision-making and resource allocation.
  • Develop business cases for new initiatives, mergers, acquisitions, and strategic partnerships.
  • Monitor the execution of strategic initiatives, tracking progress against KPIs and making necessary adjustments.
  • Present strategic recommendations and performance updates to the Board of Directors and senior management team.
  • Foster a culture of strategic thinking and innovation throughout the organization.
  • Manage external consultants and advisors as needed to support strategic planning efforts.
  • Identify and evaluate potential risks and opportunities associated with strategic decisions.
  • Ensure alignment between operational plans and strategic objectives.
Qualifications:
  • Master's degree in Business Administration (MBA), Finance, Economics, or a related field.
  • Minimum of 10 years of progressive experience in strategic planning, business development, corporate strategy, or a similar role.
  • Demonstrated success in developing and implementing complex corporate strategies that have driven significant business growth.
  • Exceptional analytical, problem-solving, and quantitative skills, with the ability to interpret complex data and translate it into strategic insights.
  • Strong understanding of financial modeling, market analysis, and competitive intelligence gathering.
  • Excellent leadership, communication, presentation, and interpersonal skills, with the ability to influence and engage stakeholders at all levels.
  • Proven experience in managing cross-functional teams and leading strategic projects.
  • Familiarity with the technology or biotech sectors is highly desirable, given the location in Cambridge.
  • Experience in a senior leadership role within a fast-paced, dynamic environment.
  • Ability to work effectively in a demanding, results-oriented culture.
This is a pivotal opportunity to shape the future direction of a leading organization.
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Head of Strategic Planning

CB2 1TN Cambridge, Eastern £80000 Annually WhatJobs

Posted 25 days ago

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full-time
Our client, a prominent research and innovation hub in Cambridge, Cambridgeshire, UK , is seeking an experienced and visionary Head of Strategic Planning. This senior leadership position is responsible for shaping and driving the organisation's long-term strategic direction, fostering growth, and ensuring alignment across all departments. You will play a critical role in identifying new opportunities, assessing market trends, and developing robust plans to achieve ambitious organisational goals. This role requires a strategic thinker with exceptional analytical and communication skills, coupled with a deep understanding of the innovation ecosystem.

Responsibilities:
  • Develop, communicate, and implement the organisation's strategic plan, ensuring its alignment with overall mission and objectives.
  • Conduct in-depth market research, competitive analysis, and scenario planning to identify key opportunities and risks.
  • Lead cross-functional teams to define strategic initiatives, set measurable objectives, and track progress.
  • Develop financial models and business cases to support strategic investments and new ventures.
  • Collaborate with senior leadership to foster a culture of strategic thinking and data-driven decision-making.
  • Monitor and evaluate the effectiveness of strategic initiatives, making necessary adjustments to ensure successful execution.
  • Identify and assess potential partnerships, mergers, and acquisitions.
  • Prepare comprehensive reports and presentations for the board of directors and key stakeholders.
  • Mentor and develop a team of strategic analysts and planners.
  • Ensure robust governance and reporting mechanisms are in place for strategic projects.
Qualifications:
  • Master's degree in Business Administration (MBA), Finance, Economics, or a related field. A Ph.D. is advantageous.
  • A minimum of 10 years of experience in strategic planning, corporate development, management consulting, or a related field, preferably within a research, technology, or innovation-focused organisation.
  • Demonstrated success in developing and executing complex strategic plans.
  • Strong analytical, quantitative, and problem-solving skills, with the ability to synthesize information from various sources.
  • Excellent financial modeling and valuation skills.
  • Exceptional written and verbal communication and presentation skills.
  • Proven ability to lead and influence diverse teams and senior stakeholders.
  • Experience in the technology or life sciences sector is highly desirable.
  • A deep understanding of strategic frameworks and business analysis tools.
  • Ability to operate effectively in a dynamic and intellectually stimulating environment.
This is an outstanding opportunity for a seasoned strategist to make a significant impact at a leading institution. The role offers a competitive salary, comprehensive benefits, and the chance to contribute to the future success of a world-renowned organisation.
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Operations Director - Strategic Planning

CB2 1SU Cambridge, Eastern £80000 Annually WhatJobs

Posted 25 days ago

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full-time
Our client, a prestigious organisation based in Cambridge, Cambridgeshire, UK , is seeking a highly accomplished Operations Director to lead strategic planning and execution across their diverse operational functions. This senior leadership role demands a visionary individual with a proven track record in optimising business processes, driving efficiency, and fostering a culture of continuous improvement. You will be responsible for overseeing key operational departments, developing and implementing long-term strategic plans, managing budgets, and ensuring the seamless integration of operations with the company's overall objectives. The ideal candidate will possess exceptional leadership qualities, strong analytical and problem-solving skills, and the ability to influence stakeholders at all levels. Experience in managing complex projects, mitigating risks, and leading large teams is essential. A deep understanding of operational best practices and a commitment to excellence are paramount.

Key Responsibilities:
  • Develop and implement comprehensive operational strategies aligned with organisational goals.
  • Oversee the day-to-day operations of multiple departments, ensuring efficiency and effectiveness.
  • Lead strategic planning initiatives, including forecasting, resource allocation, and performance management.
  • Manage departmental budgets, control costs, and identify opportunities for financial optimisation.
  • Drive process improvements and implement best practices across all operational areas.
  • Ensure compliance with all relevant regulations and industry standards.
  • Lead, mentor, and develop a high-performing team of operational managers and staff.
  • Develop and maintain key performance indicators (KPIs) to monitor operational performance.
  • Manage relationships with key stakeholders, including suppliers, partners, and internal departments.
  • Identify and mitigate operational risks, developing contingency plans as needed.
  • Champion a culture of innovation, quality, and continuous improvement.
Qualifications and Experience:
  • Extensive experience in senior management or operations leadership roles.
  • Proven track record in strategic planning, business development, and operational execution.
  • Strong understanding of financial management and budgeting principles.
  • Exceptional leadership, team management, and motivational skills.
  • Excellent analytical, problem-solving, and decision-making abilities.
  • Proficiency in operational management systems and process improvement methodologies.
  • Strong communication, negotiation, and stakeholder management skills.
  • Master's degree in Business Administration, Operations Management, or a related field is highly desirable.
  • Experience in (specific industry relevant to the fictional client, e.g., R&D, Technology, Logistics) is a plus.
This is a critical role offering significant influence and the opportunity to shape the future success of a leading organisation.
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Head of Strategic Planning & Operations

CB2 1AA Cambridge, Eastern £70000 Annually WhatJobs

Posted 3 days ago

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full-time
A highly respected research and innovation hub in **Cambridge, Cambridgeshire, UK**, is seeking an accomplished Head of Strategic Planning & Operations. This senior leadership role is integral to driving the organization's long-term vision and ensuring operational excellence across all departments. The successful candidate will be responsible for developing and executing strategic initiatives, overseeing resource allocation, and optimizing operational processes to support the organization's ambitious goals. Our client fosters a collaborative environment dedicated to pioneering advancements.

Key Responsibilities:
  • Develop, implement, and monitor the organization's strategic plan, ensuring alignment with mission and objectives.
  • Lead the annual budgeting and financial planning process, working closely with department heads to ensure fiscal responsibility.
  • Oversee operational activities, including process improvement, efficiency gains, and resource management.
  • Analyze market trends, competitive landscape, and internal performance data to identify opportunities and potential risks.
  • Manage cross-functional projects, ensuring timely and successful delivery of strategic initiatives.
  • Develop and maintain key performance indicators (KPIs) to track progress against strategic goals.
  • Facilitate strategic planning sessions and workshops with senior leadership and stakeholders.
  • Enhance organizational effectiveness through the implementation of best practices in project management, operations, and change management.
  • Build and maintain strong relationships with internal departments, external partners, and key stakeholders.
  • Prepare comprehensive reports and presentations for the board of directors and executive leadership.

Qualifications and Experience:
  • Master's degree in Business Administration (MBA), Management, Finance, or a related field.
  • A minimum of 8 years of progressive experience in strategic planning, operations management, or a related leadership role within a complex organization.
  • Proven track record of developing and implementing successful strategic plans and driving significant operational improvements.
  • Strong financial acumen, including experience with budgeting, forecasting, and financial analysis.
  • Excellent analytical, problem-solving, and critical thinking skills.
  • Exceptional leadership, communication, and interpersonal skills, with the ability to influence and motivate diverse teams.
  • Proficiency in project management methodologies and tools.
  • Experience in a research, technology, or innovation-focused environment is highly desirable.
  • Ability to think strategically and translate vision into actionable plans.

This is a pivotal role for a forward-thinking leader looking to make a substantial impact within a world-leading innovation ecosystem.
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Head of Strategic Planning & Operations

CB2 1TN Cambridge, Eastern £90000 Annually WhatJobs

Posted 6 days ago

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full-time
Our client, a globally recognised research and development institution, is seeking an accomplished and visionary Head of Strategic Planning & Operations to join their leadership team. This is a fully remote leadership role, offering the flexibility to work from anywhere in the world, provided you can align with UK working hours and participate in virtual leadership meetings. You will be instrumental in shaping the organisation's long-term strategic direction and overseeing the effective execution of operational initiatives. This role requires a blend of strategic foresight, analytical prowess, and exceptional operational management capabilities. Your responsibilities will encompass developing and refining the organisation's strategic roadmap, identifying new growth opportunities, and translating strategic goals into actionable operational plans. You will collaborate closely with department heads across research, finance, and administration to ensure alignment and resource optimisation. A key part of your role will involve evaluating and implementing operational improvements, managing key projects, and ensuring the organisation is well-positioned for sustained growth and innovation. Strong data analysis, financial acumen, and project management skills are essential. Key Responsibilities:
  • Develop, articulate, and manage the organization's strategic plan and long-term vision.
  • Identify and evaluate new market opportunities, strategic partnerships, and potential growth areas.
  • Translate strategic objectives into actionable operational plans and key performance indicators (KPIs).
  • Oversee the planning and execution of major strategic initiatives and projects.
  • Conduct market research, competitive analysis, and scenario planning to inform strategic decisions.
  • Collaborate with financial teams to develop budgets and financial forecasts aligned with strategic goals.
  • Drive operational efficiency and effectiveness across all departments through process improvement initiatives.
  • Provide strategic guidance and support to executive leadership and department heads.
  • Develop and maintain reporting frameworks to track progress against strategic objectives.
  • Foster a culture of strategic thinking and continuous improvement throughout the organization.
Qualifications:
  • Master's degree in Business Administration (MBA), Strategy, Finance, or a related field.
  • 10+ years of progressive experience in strategic planning, business development, and/or operations management, preferably within a research-intensive or technology-driven environment.
  • Proven track record of developing and implementing successful corporate strategies.
  • Strong analytical, problem-solving, and critical thinking skills.
  • Exceptional leadership, communication, and stakeholder management abilities.
  • Experience in financial modelling, budgeting, and performance management.
  • Proficiency with project management methodologies and tools.
  • Demonstrated ability to influence and collaborate with senior stakeholders.
This leadership role offers a unique opportunity to shape the future of a leading R&D institution on a global scale, from a remote working setup.
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Senior Operations Manager, Strategic Planning

CB2 1TN Cambridge, Eastern £60000 Annually WhatJobs

Posted 9 days ago

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full-time
Our client, a rapidly growing technology firm, is seeking a highly strategic and results-oriented Senior Operations Manager to oversee key operational functions and drive strategic planning initiatives. This is a critical on-site role based at our prestigious **Cambridge, Cambridgeshire, UK** headquarters. You will be responsible for optimizing operational efficiency, developing long-term strategic plans, and ensuring the seamless execution of business objectives. Your leadership will be instrumental in streamlining processes, managing resources effectively, and fostering a culture of continuous improvement across departments. Key responsibilities include developing and implementing operational strategies aligned with the company's vision; managing budgets, resource allocation, and project timelines; overseeing cross-functional teams to ensure project success; identifying and implementing process improvements to enhance productivity and reduce costs; developing and monitoring key performance indicators (KPIs) to track operational performance; collaborating with senior leadership to formulate and execute strategic plans; managing vendor relationships and ensuring service level agreements (SLAs) are met; and mentoring and developing operations staff. The ideal candidate will possess a strong background in operations management, strategic planning, and process optimization, preferably within the technology sector. Proven experience in managing complex projects and cross-functional teams is essential. Exceptional analytical, problem-solving, and leadership skills are required. A Bachelor's degree in Business Administration, Operations Management, or a related field is required; an MBA or relevant professional certification is highly desirable. Excellent communication, negotiation, and stakeholder management skills are vital for working with diverse internal and external parties. This role demands a proactive, highly organized, and forward-thinking individual capable of driving significant operational improvements and contributing to the company's sustained growth.

Responsibilities:
  • Develop and execute strategic operational plans to achieve company objectives.
  • Oversee daily operations, ensuring efficiency, quality, and adherence to standards.
  • Manage departmental budgets and resource allocation effectively.
  • Lead and mentor operations teams, fostering a collaborative and high-performance culture.
  • Identify and implement process improvements to optimize workflow and reduce costs.
  • Establish and monitor Key Performance Indicators (KPIs) to measure operational success.
  • Collaborate with senior management on strategic initiatives and business development.
  • Manage vendor relationships and ensure compliance with contracts and SLAs.
  • Conduct risk assessments and develop mitigation strategies for operational challenges.
  • Prepare operational reports and present findings to executive leadership.
Qualifications:
  • Proven experience in Operations Management or a similar strategic leadership role.
  • Strong background in strategic planning, process improvement, and project management.
  • Demonstrated leadership skills with experience managing diverse teams.
  • Excellent analytical, problem-solving, and decision-making abilities.
  • Proficiency in budgeting, financial management, and resource planning.
  • Strong understanding of operational best practices and performance metrics.
  • Excellent communication, negotiation, and interpersonal skills.
  • Bachelor's degree in Business Administration, Operations Management, or a related field; MBA preferred.
  • Ability to thrive in a fast-paced, dynamic business environment.
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Senior Strategic Planning Manager (Remote)

CB2 1 Cambridge, Eastern £80000 Annually WhatJobs

Posted 13 days ago

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full-time
Our client, a leading global conglomerate, is seeking an exceptional Senior Strategic Planning Manager to join their fully remote, highly collaborative team. This pivotal role involves shaping the future direction of the organization by developing and implementing long-term strategic initiatives. You will be instrumental in identifying market opportunities, analyzing competitive landscapes, and formulating actionable plans that drive sustainable growth and profitability. The ideal candidate will possess a sharp analytical mind, exceptional strategic thinking abilities, and a proven track record of influencing executive decision-making in a complex business environment. This remote position requires a proactive, self-motivated individual who thrives on tackling challenging business problems.

Responsibilities:
  • Lead the development and execution of the company's long-term strategic plan, aligning business objectives with market trends and competitive dynamics.
  • Conduct in-depth market research, competitive intelligence gathering, and scenario planning to identify strategic opportunities and potential risks.
  • Analyze financial performance and operational data to assess the effectiveness of current strategies and identify areas for improvement.
  • Develop business cases for new strategic initiatives, including market entry, product development, and potential acquisitions or partnerships.
  • Collaborate with senior leadership across various departments to ensure buy-in and alignment on strategic priorities.
  • Facilitate strategic planning workshops and cross-functional team meetings, driving consensus and action planning.
  • Monitor the implementation of strategic initiatives, track progress against key performance indicators (KPIs), and recommend adjustments as needed.
  • Prepare high-level presentations and reports for the board of directors and executive management, articulating strategic vision and recommendations.
  • Mentor and guide junior members of the strategy team, fostering their professional development.
  • Stay abreast of global economic trends, technological advancements, and regulatory changes that may impact the company's strategic direction.
Qualifications:
  • MBA or Master's degree in Business Administration, Strategy, Finance, or a related field.
  • 10+ years of experience in strategic planning, corporate development, management consulting, or a similar role, preferably within a large, complex organization.
  • Demonstrated experience in developing and implementing successful corporate strategies.
  • Exceptional analytical, problem-solving, and critical thinking skills.
  • Proven ability to conduct rigorous market and competitive analysis.
  • Strong understanding of financial modeling and valuation techniques.
  • Excellent leadership, communication, and presentation skills, with the ability to influence senior stakeholders.
  • Experience managing cross-functional projects and driving change initiatives.
  • Proficiency in strategic planning frameworks and tools.
  • Ability to work independently and collaboratively in a remote setting.
  • Must be eligible to work in the UK.
This is a fully remote position, offering the flexibility to work from anywhere within the UK. Join a forward-thinking organization and shape its future success. The role is based in the Cambridge, Cambridgeshire, UK area, but requires full-time remote work.
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Senior Operations Manager - Strategic Planning

CB23 8RF Cambridge, Eastern £75000 Annually WhatJobs

Posted 17 days ago

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full-time
Our client is seeking a highly accomplished and strategic Senior Operations Manager to lead critical operational functions within a dynamic, global organization. This is a fully remote position, offering the flexibility to work from anywhere within the UK. The successful candidate will be responsible for developing and implementing operational strategies that align with the company's long-term objectives, driving efficiency, and fostering a culture of continuous improvement.

Key Responsibilities:
  • Develop and execute comprehensive operational plans, policies, and procedures to enhance efficiency and productivity across multiple departments.
  • Oversee and manage the operational budget, ensuring cost-effectiveness and optimal resource allocation.
  • Lead and mentor a distributed team of operational professionals, fostering collaboration and high performance in a remote setting.
  • Identify and implement process improvements and best practices using data-driven insights and performance metrics.
  • Manage key stakeholder relationships, both internal and external, to ensure alignment and effective communication.
  • Conduct regular performance reviews and provide constructive feedback to team members.
  • Mitigate operational risks and develop contingency plans to ensure business continuity.
  • Stay abreast of industry trends and emerging technologies to maintain a competitive operational edge.
  • Champion a remote-first work environment, ensuring seamless communication and engagement across geographically dispersed teams.
  • Drive strategic initiatives that support the company's growth and market expansion.

Qualifications:
  • Proven track record in a senior management role with extensive experience in operational strategy and execution.
  • Demonstrated experience in managing remote teams and fostering a productive virtual work environment.
  • Exceptional leadership, communication, and interpersonal skills.
  • Strong analytical and problem-solving abilities, with a data-driven approach to decision-making.
  • Experience with budget management and financial forecasting.
  • Bachelor's degree in Business Administration, Operations Management, or a related field. A Master's degree is a plus.
  • Proficiency in project management methodologies and tools.
  • Ability to work independently and take initiative in a remote setting.
  • Deep understanding of operational KPIs and how to leverage them for strategic advantage.

This role is ideal for a seasoned leader looking to make a significant impact from a remote location. The successful candidate will play a pivotal role in shaping the future operational landscape of our client. The Cambridge region serves as a conceptual hub for this role, but the work is performed entirely remotely.

Join our forward-thinking organization and contribute to our ongoing success by driving operational excellence from anywhere in the UK.
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