Overview
In this role you will be the expert steering risk-based quality management across global clinical development. You’ll embed quality principles early in trial design and oversee continuous quality improvements to keep trials inspection-ready. You will partner with CROs, vendors, and international teams to define tolerance limits, manage risks, and support regulatory inspections. This position offers impact across therapeutic areas in Oncology, Neurology, and Fertility within a diverse, inclusive culture. Join us to help ensure safe, effective medicines and devices reach patients at scale.
Pay / Benefits
- inclusion and belonging culture
- personal development and career advancement
- global opportunities
- flexible working arrangements
- employee well-being programmes
- competitive compensation
Responsibilities
- Serve as SME in risk-based quality management across the clinical development lifecycle
- Lead implementation and continuous improvement of quality processes to identify critical data and processes and proactively manage risks
- Ensure trials are consistently inspection-ready and support regulatory inspections
- Collaborate with CROs, vendors, and international study teams to define quality tolerance limits and maintain risk management plans
- Lead investigations and responses to quality issues to drive continuous improvement across trials
- Support risk-based monitoring strategies and maintain GCP inspection readiness throughout the trial lifecycle
- Co-lead preparation for regulatory authority inspections
Key requirements
- Degree in medical science, life science, or related field (postgraduate preferred)
- At least eight years experience across the full clinical development lifecycle (design, start-up, conduct, analysis, reporting)
- Deep expertise in clinical quality risk management, Quality by Design, risk-based monitoring, and GCP inspection readiness
- Strong regulatory knowledge and familiarity with international harmonisation guidelines
- Experience supporting or co-leading regulatory inspections and maintaining inspection-readiness tools and plans
- Experience working with CROs and external vendors in an international, cross-functional matrix environment
- Strong analytical and project management abilities; ability to translate data into actionable insights
- Clear, confident communication with diverse audiences; influencing without authority
- Proactive, accountable, and capable of independent work in a multinational setting
- Willingness to coach colleagues and support continuous improvement
- Clear and confident communication
- Influencing without authority
- Proactivity and accountability
- Clinical quality risk management
- Quality by Design
- Risk-based monitoring
Assoc Dir., Clinical Quality Mgmt. Lead in London employer: Merck
Join a dynamic team in Livingston where innovation meets inclusivity! As a Production Operator in our cleanroom, you'll benefit from a supportive work culture that values diverse perspectives and fosters personal growth. With opportunities for professional development and a commitment to employee well-being, we empower you to make a meaningful impact in the fields of Healthcare, Life Science, and Electronics.
