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 experienced and strategically oriented QA Director for Chemical Intermediates (CI), Biological Intermediates (BI), and Drug Substance (DS) to lead Quality Assurance oversight of CI, BI, and DS activities supporting commercial products, all manufactured through external partners.

This role plays a critical part in safeguarding product quality, patient safety, and supply reliability in a fully outsourced manufacturing model. In addition, the role carries responsibility for building and scaling a fit-for-purpose QA organization for CI, BI, and DS over the coming years, aligned with the expansion of Genmab's commercial portfolio and global CMO network.

You will be part of the global GMP QA organization and a key member of the QA leadership team, reporting directly to the Team Lead of QA GMP Commercial.

Key Responsibilities

The responsibilities of the QA Director for CI / BI / DS will include, but not be limited to:

• Define and drive the QA strategy for CI, BI, and DS supporting commercial products in a fully outsourced manufacturing model.

• Provide end-to-end QA oversight of commercial CI, BI, and DS manufacturing activities at CMOs, ensuring sustained GMP compliance and supply continuity.

• Hold overall responsibility for QA release of CI, BI, and DS, including establishment of release strategies, governance, and escalation pathways.

• Ensure robust review and approval of batch documentation and manufacturing data supporting release decisions, in accordance with Genmab's Pharmaceutical Quality System.

• Build, scale, and develop the CI / BI / DS QA organization, including defining future capabilities, roles, and competencies in line with business growth.

• Lead, mentor, and develop a growing QA team, fostering a strong quality culture and ensuring succession and knowledge management.

• 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 commercial CI, BI, and DS manufacturing.

• Ensure QA oversight of continued process verification, ongoing validation, and lifecycle management for commercial processes.

• Drive inspection readiness and lead QA support for regulatory inspections at CMOs, including routine and for-cause inspections.

• Plan, perform, and follow up on audits of CMOs and critical suppliers supporting commercial manufacturing.

• Provide QA input to regulatory submissions, variations, and post-approval changes related to CI, BI, and DS.

• Act as a key QA interface to Supply Chain, proactively identifying and mitigating quality-related risks to commercial supply.

• Contribute to continuous improvement of Genmab's Pharmaceutical Quality System with focus on commercial operations and outsourced manufacturing.

What We Are Looking For

• You hold a MSc degree in life science.

• Minimum 10 years of experience within the pharmaceutical industry, with extensive GMP QA experience supporting commercial CI, BI, and/or Drug Substance manufacturing at CMOs.

• Proven experience building and scaling QA teams in response to business growth and increasing complexity.

• Strong understanding of biologics manufacturing (e.g. monoclonal antibodies) and associated intermediates; experience with chemical intermediates is an advantage.

• Demonstrated experience with commercial-stage CMO oversight, quality agreements, audits, and regulatory inspections.

• Strong people leadership and organizational design capabilities.

• Solid knowledge of global GMP and ICH requirements and post-approval lifecycle management.

• Comfortable operating in a high-complexity, supply-critical environment.

• Excellent English communication skills and a pragmatic, risk-based QA mindset.

What You'll Gain

• A QA leadership role with direct impact on commercial product quality, patient safety, and supply reliability.

• The opportunity to build and mature a scalable QA organization supporting a growing commercial portfolio.

• A role combining long-term strategic ownership with hands-on engagement in complex, supply-critical manufacturing…