Erstellt am 20. Juli 2026
Senior Director, Head of Inspection & TMF Center of Excellence (all genders)
Merck Group
Darmstadt, Germany
Vollzeit
Reference: 1648305386
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 is open across Germany, Switzerland and the US, 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
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 is open across Germany, Switzerland and the US, 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
- PhD or MS in Life Sciences with 15+ years in Pharmaceutical R&D and 10+ years in multinational line management.
- Deep expertise in GCP, global Health Authority inspections, TMF governance, and eTMF platform design and implementation.
- Proven track record in Risk-Based Quality Management and delivering digital solutions for inspection readiness.
- Strong leadership capabilities with experience building, mentoring, and advancing a high-performing, diverse team.
- Exceptional stakeholder management and communication skills, with experience guiding senior leadership and cross-functional partners.
- Demonstrated ability to sponsor training programs, drive inspections simulations, and manage readiness initiatives end-to-end.
- Familiarity with ICH, FDA, EMA, MHRA, and PMDA regulatory expectations and modern QA frameworks.
- Fluency in English
Department: HC-RD-DQ Clinical Quality Management
Job evaluation: AT - Manager 5
