Merck Healthcare
Assoc Dir., Clinical Quality Mgmt. Lead
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Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! 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. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
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Our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
Your Role
At the heart of global clinical development, 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 the earliest stages of clinical trial design through to completion. You will lead the implementation and continuous improvement of quality processes across the clinical development lifecycle, ensuring that critical data and processes are identified, risks are proactively managed, and trials are consistently inspection-ready. Working closely with contract research organisations, vendors, 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. You will also lead the investigation of and response to quality issues, driving accountability and continuous improvement across assigned trials.
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The role could be based either in the UK or in Poland.
Who You Are
- A degree in medical science, life science, or a related field (a postgraduate qualification is preferred).
- At least eight years of hands-on experience spanning the full clinical development lifecycle, including trial design, start-up, conduct, analysis, and reporting.
- Deep expertise in clinical quality risk management, Quality by Design principles, risk-based monitoring, and Good Clinical Practice inspection readiness, with a strong working knowledge of international regulatory requirements and harmonisation guidelines.
- Direct experience supporting or co-leading regulatory authority inspections and confident in maintaining inspection-readiness tools and quality risk management plans throughout the trial lifecycle.
- Experienced in working with contract research organisations and external vendors in an international, cross-functional matrix environment, and can effectively oversee third-party quality performance.
- Strong analytical and project management capabilities, with a proven ability to identify critical-to-quality risks, define meaningful quality tolerance limits, and translate complex quality data into clear, actionable insights for diverse stakeholders.
- Communicates with clarity and confidence, skilled at influencing without authority, and can explain complex regulatory and quality topics to both technical and non-technical audiences across all levels of an organisation.
- Proactive, accountable, and committed to continuous improvement, with the ability to work independently in a complex multinational environment while actively supporting and coaching colleagues.
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