UK Affiliate Quality Director & Responsible Person (RP/RPi)

Genmab · City Of, UK

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Role summary

Genmab seeks a UK Affiliate Quality Director to establish and lead the Quality Management System for its UK affiliate, serving as the nominated Responsible Person under the Wholesale Distribution Authorisation. This strategic and operational role combines quality leadership, regulatory compliance, and independent authority to safeguard product quality and patient safety.

What they're looking for

Degree in pharmacy, pharmaceutical sciences, life sciences, or related discipline
MHRA RPi eligibility: acceptable qualifications, relevant experience, professional body membership
10+ years progressive pharmaceutical Quality experience
Substantial hands-on GDP experience within UK medicines supply chain
Demonstrated independent Quality judgement and regulatory compliance expertise
Experience establishing Quality Management Systems and wholesale distribution operations

What you'll be doing

Lead Quality workstream for UK affiliate establishment and wholesale distribution authorisation launch
Fulfil Responsible Person statutory duties under UK pharmaceutical legislation and MHRA requirements
Establish, maintain and continuously improve the affiliate Quality Management System and procedures
Manage deviations, CAPAs, change controls, GDP self-inspections and quality risk management
Oversee product handling, complaints, recalls, traceability and approval of distribution partners

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Date posted3 days ago

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