Senior Director, Head of Inspection & TMF Center of Excellence (all genders)

Das ist der Job

Senior Director, Head of Inspection & TMF Center of Excellence (all genders) Work Your Magic with us!

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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.

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.

Apply now Become part of a team dedicated to sparking discovery and elevating humanity. 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.

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.

What we offer We are committed to creating access and opportunities for all to develop and grow at your own pace, fostering a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress.