German Affiliate Quality Director & Responsible Person (RP)

Genmab · Bavaria, Germany

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Role summary

Genmab seeks a Quality Director for its German affiliate to establish and maintain the Quality Management System, ensure GDP compliance, and serve as the statutory Responsible Person for wholesale distribution operations in Germany.

What they're looking for

Degree in pharmacy, pharmaceutical sciences, life sciences, or related discipline
Qualifications and experience meeting German Responsible Person requirements for pharmaceutical wholesale distribution
Approximately 10+ years progressive pharmaceutical Quality experience with substantial hands-on involvement
Deep knowledge of EU GDP Guidelines and German pharmaceutical legislation
Experience establishing Quality systems and managing affiliate operations
Strong regulatory inspection and compliance management background

What you'll be doing

Lead Quality workstream for German affiliate establishment and wholesale distribution authorization
Fulfill Responsible Person statutory duties under German and EU pharmaceutical regulations
Establish and maintain the affiliate Quality Management System with procedures and training
Manage deviations, CAPAs, change controls, quality complaints and distribution incidents
Oversee product traceability, recall management, supplier qualification and third-party logistics oversight

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Date posted3 days ago

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