Director, Senior Clinical Quality Management Lead (all genders) - full-time

at  Merck Group

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.
United As One for Patients, 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.

The Clinical Quality Management (CQM) Lead is essential in implementing risk-based quality management for clinical trials. Key responsibilities include leading the identification of critical to quality factors, leading quality risk identification, prioritization and mitigation, and overseeing predefined acceptable ranges (e.g., Quality Tolerance Limits - QTLs). The CQM Lead ensures continuous quality improvement and maintains inspection readiness at all times, providing guidance on Good Clinical Practice (GCP) quality principles.
This role involves integrating operational feasibility and stakeholder insights into clinical protocols and quality risk management plans. The CQM Lead supports study teams in developing risk-based monitoring plans, investigates quality issues, assesses their impact, and implements corrective and preventive actions. Collaboration with R&D Quality to co-lead inspection preparation activities is also crucial. The ideal candidate will demonstrate strong leadership, influencing, and project manageement skills and a commitment to maintaining high-quality standards throughout the clinical trial process.