Associate Director, GMP QA
GenmabCapital Region of Denmark, Denmark
Posted November 21, 2025
Full Time
About the Company
Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics.
Job Description
Genmab is seeking an enthusiastic and experienced GMP QA Associate Director for our brand-new Clinical Packaging & Labelling Facility. The role will set the quality direction for the Clinical Pack & Label activities and take part in certification of IMP for Genmab clinical trials.
Requirements
- Lead QA oversight of packaging & labelling activities, including review and approval of Master Batch Records (MBRs), SOPs, and logbooks.
- Perform delegated QP certification of IMP batches for clinical trials.
- QA approver of qualification and validation of equipment and processes.
- Drive inspection readiness and ensure continuous GMP compliance of documentation and procedures.
- Promote collaborative relations with internal stakeholders and external partners to support a seamless supply chain.
- Perform audits and evaluations of suppliers and contractors relevant for the Packing and labelling site and operations.
- Manage quality records such as deviations, CAPAs, and change controls.
- Contribute to updates and improvements to Genmab’s Pharmaceutical Quality System.