Associate Director, Team Lead, QA GMP

About the role

Genmab is seeking an experienced QA Associate Director for GMP QA Development - Drug Product (DP) & Clinical Supply to provide strategic and operational QA oversight of development manufacturing activities, primarily performed through external manufacturing partners. The role is central to ensuring product quality, patient safety, and reliable clinical supply across a fully outsourced development manufacturing network. In close collaboration with CMOs and cross-functional stakeholders, you will help sustain a strong quality culture and ensure compliance with applicable GMP requirements throughout the development lifecycle. In this role, you will apply your quality and leadership expertise as part of Genmab's global GMP QA organization, supporting development programs and outsourced DP and IMP manufacturing activities. The position is based in Denmark and reports to the Director of GMP QA Development, Drug Product & Clinical Supply.

Responsibilities

• The QA Associate Director's responsibilities will include:
• Lead, coach, and develop a team of 5 to drive high performance, engagement, accountability, and professional growth.
• Define team priorities, operational standards, and ways of working that support collaboration, compliance, and inspection readiness.
• Build and maintain strong stakeholder relationships to enable timely, compliant delivery.
• Lead and contribute to cross-functional projects and strategic initiatives within the QA organization.
• Provide end-to-end QA oversight of DP and IMP manufacturing activities, both internally and at CMOs, to ensure sustained GMP compliance and continuity of clinical trial supply.
• Act as QP delegate for DP and IMP activities.
• Ensure independent, documented, risk-based batch disposition decisions and batch release within delegated authority and applicable GMP legislation.
• Oversee deviations, CAPAs, change controls, and risk assessments related to clinical DP, Clinical Supply, manufacturing, and packaging activities.
• Support internally manufactured clinical supply activities at Genmab Site Ballerup.
• Oversee suppliers and Contract Manufacturing Organizations (CMOs), including quality agreements and governance models that ensure clear accountability and escalation pathways.
• Plan, conduct, and follow up on internal audits as well as audits of CMOs and critical suppliers.
• Support audits and regulatory inspections, as applicable.
• Drive inspection readiness and lead QA support for routine and for-cause regulatory inspections at CMOs.
• Provide QA input to regulatory submissions, variations, and development-related changes for Drug Product and Clinical Supply.
• Support continuous improvement of Genmab's Pharmaceutical Quality System.

Requirements

• MSc degree or equivalent qualification in Life Sciences.
• Minimum 10 years of pharmaceutical industry experience, including extensive GMP QA experience supporting clinical Drug Product and IMP activities.
• At least 5 years of leadership experience managing a specialized team.
• Experience as a QP delegate for DP and IMP activities; experience with post-trial access, Named Patient Use, or Access Programs is an advantage.
• Strong understanding of aseptic Drug Product manufacturing, preferably involving monoclonal antibodies or other biologics.
• Solid GMP experience within IMP and Clinical Supply.
• Solid experience with development-stage CMO oversight, quality agreements, audits, and regulatory inspections.
• Excellent English communication skills and a pragmatic, risk-based QA mindset.
• A positive, collaborative mindset with the ability to thrive in an ambitious, dynamic environment characterized by change and continuo

Additional Information

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!

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