Associate Director, QA GMP

Associate Director, QA GMP

Genmab

Copenhagen, Denmark

The Role

Genmab is seeking an experienced QA Associate Director for GMP QA Development – Drug Product & Clinical Supply to provide strategic and operational Quality Assurance oversight of development-stage manufacturing activities supporting clinical trials, conducted mainly through external manufacturing partners.

This role is key to ensuring product quality, patient safety, and reliable supply within a fully outsourced development manufacturing network. Working closely with CMOs and cross-functional stakeholders, you will contribute to maintaining a strong quality culture and ensuring compliance with applicable GMP requirements throughout the development lifecycle.

You will become part of Genmab’s global GMP QA organization and play an important role in supporting development programs and outsourced manufacturing activities for DP and IMP. The position is based in Denmark and reports to the Director of GMP QA Development, Drug Product & Clinical Supply. Our Global QA Department has over 50 GXP professionals across Denmark, the Netherlands, the US, Japan, and China.

Key Responsibilities

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

• Provide end-to-end QA oversight of DP, IMP manufacturing activities internally and at CMOs, ensuring sustained GMP compliance and supply continuity for clinical trials.
• Act as a QP delegate for DP, IMP.
• Maintain independent, documented, and risk-based decision-making for batch disposition.
• Support clinical supply manufactured internally at the Genmab Site Ballerup.
• Oversee Supplier and Contract Manufacturing Organisations (CMOs).
• Plan, perform, and follow up on audits, both internal and audits of CMOs and critical suppliers.
• Ensure batch release within delegated authority in accordance with applicable GMP legislation.
• Serve as a role model and mentor by guiding and supporting less experienced colleagues, fostering collaboration, development, and high professional standards.
• Ensure development-stage batches comply with approved specifications, GMP requirements, and applicable clinical regulatory requirements prior to disposition/release.
• Support audits and regulatory inspections when applicable.
• Ensure robust review and approval of batch documentation and manufacturing data supporting release decisions, in accordance with Genmab’s Pharmaceutical Quality System.
• Establish and maintain robust quality agreements and governance models with CMOs, ensuring clear accountability and escalation pathways.
• Oversee deviations, CAPAs, change controls, and risk assessments related to DP and Clinical Supply manufacturing activities.
• Drive inspection readiness and lead QA support for regulatory inspections at CMOs, including routine and for-cause inspections.
• Provide QA input to regulatory submissions, variations, and development-related changes associated with Drug Product and Clinical Supply.
• Contribute to continuous improvement of Genmab’s Pharmaceutical Quality System with focus on development and outsourced manufacturing operations.

In this Associate Director role, you will work closely with your GMP QA team, your stakeholders in Technical Operations, Regulatory Affairs and CMOs on DP and Clinical Supply. This position offers a valuable opportunity to contribute to development projects within GMP QA. Genmab maintains an innovative portfolio of products designed to advance cancer therapy.

Requirements

• You hold an MSc degree (preferably Cand.pharm.) or equivalent within Life Sciences.
• You bring a minimum of 10 years of experience from the pharmaceutical industry, including extensive GMP QA experience supporting Clinical Drug Product and IMP.
• You have experience as a QP delegate on DP, IMP. Experience with post-trial access, Named Patient Use, Access Programs is an advantage.
• You have a strong understanding of Drug Product biologics manufacturing (e.g., monoclonal antibodies).
• You have experience with manufacturing of IMP, Clinical Supply.
• You possess solid experience with development-stage CMO oversight, quality agreements, audits, and regulatory inspections.
• You communicate fluently in English and apply a pragmatic, risk-based QA mindset in your work.
• As a person, you thrive in an ambitious and dynamic environment and enjoy working in a setting characterized by change and continuous development. You bring a positive mindset, value strong collaboration, and contribute as a supportive and trusted colleague across teams and stakeholders.

About You

• 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!