Associate Director, GMP QA

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.

Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.

Does this inspire you and feel like a fit? Then we would love to have you join us!

The Role

Genmab is seeking an enthusiastic and experienced GMP QA Associate Director for our brand-new Clinical Packaging & Labelling Facility. In this newly established role, you will set the quality direction for the Clinical Pack & Label activities and as delegated Qualified Person take part in certification of IMP for Genmab clinical trials.

The In-house packaging facility is part of Genmab's Technical Operations organization and located in Ballerup which will be your main place of work. The packaging facility will, when ready, be responsible for supporting Genmab's innovative products by performing packaging and labelling activities for clinical trials.

As GMP QA Associate Director you will be an important part of the global GMP QA team to ensure compliance to industry standards and regulations. The role does not include people management.

The QA GMP team at Genmab currently employs 40 people located in Denmark, China and US. Our new colleague will report to Team Lead QA GMP Early Development located in Valby, Denmark.

Key Responsibilities

The responsibilities of the GMP QA Associate Director will include, but not be limited to:

• 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.

• You hold a MSc degree or equivalent in a relevant life science subject.
• You have +10 years' experience from the pharmaceutical industry preferably including in-house manufacturing.
• Solid knowledge of GMP and clinical development processes.
• Experience with IMP, or AxMPs is a strong plus.
• Lead auditor experience is an advantage.
• You will bring hands-on, pragmatic approach with excellent problem-solving skills.
• You have a collaborative mindset, capable of thriving in a fast-paced, evolving environment.
• Excellent written and verbal communication skills in English.

• You are genuinely passionate about our purpose
• You bring precision and excellence to all that you do
• You believe in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds
• You take pride in enabling the best work of others on the team
• You can grapple with the unknown and be innovative
• You have experience working in a fast-growing, dynamic company (or a strong desire to)
• You work hard and are not afraid to have a little fun while you do so!