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Merck Group

Associate Director, Clinical Quality Management Lead

United KingdomHybrid
PermanentFull-Time
Sign up to unlock the estimation.Sign up to unlock the estimation85,000 - £110,000per annumMeev estimate
Posted 1 week ago

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Description

Work Your Magic with us!

Ready to explore, break barriers, and discover more? Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics.

Your Role

At the heart of global clinical trials, quality is not a checkpoint, it is a discipline that shapes every decision. In this pivotal role, you will serve as a subject matter expert in risk-based quality management, guiding cross-functional study teams to embed quality principles from trial design through to completion.

You will lead the implementation and continuous improvement of quality processes across the clinical development lifecycle, ensuring critical data and processes are identified, risks are managed proportionately, and trials are consistently inspection-ready. Working with service providers and international study teams, you will define quality tolerance limits, maintain quality risk management plans, support risk-based monitoring strategies, and co-lead preparation for regulatory authority inspections.

The role could be based either in Poland or the UK. This role requires on-site presence for 3 days per week.

Who You Are

  • Degree in medical science, life science, or a related field (postgraduate preferred), with at least eight years of hands-on experience across the full clinical development lifecycle.
  • Substantial hands-on experience in clinical trial operations within a contract research organisation or sponsor study team.
  • Deep expertise in clinical quality risk management, Quality by Design, risk-based monitoring, and Good Clinical Practice inspection readiness.
  • Direct experience supporting or co-leading regulatory authority inspections.
  • Experience working with CROs and external vendors in an international, cross-functional matrix environment.
  • Strong analytical and project management capabilities, with the ability to define quality tolerance limits and translate quality data into actionable insights.
  • Clear, confident communicator who influences without authority and explains complex topics to varied audiences.
  • Proactive, accountable, and committed to continuous improvement.


Your main benefits
  • Health and well-being: private medical care, life insurance, sports card, prepaid lunch card.
  • Work-life balance: additional paid days off, flexible working hours.
  • Learning and development: co-financing for language courses, trainings, and certifications.
  • Employee support: Employee Assistance Program and engagement groups.


Information on how we process your personal data for recruitment purposes can be found in our Recruitment Portal.
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Merck Group logo

Merck Group

A science and technology company solving complex challenges across healthcare and electronics

DarmstadtPharma1000+

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