Associate Director, PV/GCP Quality Assurance

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Associate Director, PV/GCP Quality Assurance

Hørsholm

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Y-mAbs Therapeutics A/S is looking for an Associate Director, Quality Assurance in the area of Pharmacovigilance (PV) and Drug Safety, who will be part of a team of highly qualified and motivated colleagues.

It is our expectation that this person will establish QA processes to contribute to Good Pharmacovigilance Practice (GVP) and Good Clinical Practice (GCP) compliance of the company operations.

Key responsibilities

Contribute to development of the company Quality Management System and provide guidance in local and global requirements, as applicable to Pharmacovigilance and Clinical Drug Safety
Maintain Quality oversight of Pharmacovigilance System Master File, pharmacovigilance SOPs, Safety Management Plans, Pharmacovigilance Agreements, and other relevant documents