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

Unternehmen:
Merck Group
Unternehmen:
Ort(e):
Darmstadt
Arbeitsmodell:
Führungsposition in Teilzeit
Quelle:
Online
Online
Online

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.

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