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Provide expert advice on GVP compliance and regulatory matters, acting as quality partner to PV Operations (US/DK) and the EU QPPV. Author and maintain GVP Quality procedures and support implementation of new or updated GVP requirements.
You’ll oversee Genmab’s commercial programs, coordinating and planning activities with our partnered CMOs. You’ll collaborate closely with colleagues in LSMD, the commercial supply chain, regulatory affairs, and QA to ensure seamless operations.
Your key responsibilities will be to influence the performance of the quality system and the PV activities; to promote, maintain and improve compliance with the legal requirements; to maintain an overview of medicinal product safety profiles and any