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.
Your role
We are seeking a Director-level leader to head its Inspection & Trial Master File (TMF) Center of Excellence within the Global Development Operations (GDO) Clinical Quality Management (CQM) organization. This office-based (3 days on site per week) role can be filled either in Switzerland (Eysins) or the US (Billerica), and represents a high-impact senior strategic position for an experienced GCP quality, inspection, and TMF leader in the clinical trial operations space.
The Head of Inspection & TMF Center of Excellence encompasses three core areas of responsibility. In the area of Inspection Excellence, the successful candidate will establish and lead a global "Always Inspection Ready" operating model, providing GDO strategic oversight of Health Authority inspections. This includes sponsoring GDO training programs, leading portfolio-wide GDO inspection simulations, acting as GDO Executive Inspection Lead for Health Authority inspections, and continuously improving readiness frameworks through trend analysis and cross-functional collaboration.
As head of the TMF Center of Excellence, the role owns the global TMF governance framework, ensuring alignment with key regulatory standards including ICH E6(R2/R3), FDA 21 CFR Part 11, EMA, MHRA, and PMDA requirements and serves as the business lead for the TMF system. Core responsibilities include maintaining the TMF Reference Model, establishing a global TMF health metrics dashboard, driving digital modernization through automation and AI, and leading continuous improvement of TMF processes, tools, and systems. Across Quality Excellence more broadly, the leader will oversee GDO-wide audits and quality management, ensuring risk-based, data-driven decision-making while fostering a strong culture of proactivity, accountability, and continuous improvement.
The position involves managing a high-performing, multinational team — setting objectives, conducting performance reviews, defining team structure, and supporting career development and capability building across varying seniority levels.
Who you are
Department: HC-RD-DQ Clinical Quality Management
Job evaluation: AT - Manager 5
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
This channel is not intended for U.S. and Canadian visitors. Merck operates in the U.S. and Canada as EMD Serono in Healthcare, MilliporeSigma in Life Science and EMD Electronics in Electronics. An unaffiliated and unrelated company, Merck & Co., Inc., Kenilworth, NJ, US holds the rights in the trademark MERCK in the U.S. and Canada.
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We are Merck, a leading global science and technology company headquartered in Germany.
We are curious explorers, courageous pioneers, and ingenious inventors. Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Life Science, Healthcare, and Electronics.
Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and the planet.
We believe in the positive power of science and technology. It has determined our actions since 1668 and inspires us to continue researching for a future worth living. As a family-owned company with over 350 years of experience, we stand for sustainability, responsibility, and innovative strength.
We take pride in being a diverse and inclusive company that values and fosters the talents and abilities of our employees. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
Work your Magic and join Merck.
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