Director, QA Commercial - Drug Product & Finished Goods

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!

• Define and drive the QA strategy for DP and FG supporting commercial products in a fully outsourced manufacturing and packaging model.
• Provide end-to-end QA oversight of commercial DP and FG manufacturing, packaging, labeling, and distribution activities at CMOs.
• Hold overall responsibility for QA release of Drug Product and Finished Goods, including establishment of release strategies, governance models, and escalation pathways.
• Ensure robust review and approval of batch records, packaging documentation, and associated quality data supporting release decisions, in accordance with Genmab's Pharmaceutical Quality System.
• Build, scale, and develop the DP / FG QA commercial organization, including defining future capabilities, roles, and competencies in line with business growth and market expansion.
• Lead, mentor, and develop a growing QA team, fostering a strong quality culture, succession planning, and knowledge management.
• Establish and maintain robust quality agreements and governance models with DP/FG CMOs, ensuring clear accountability for batch disposition, release, and escalation.
• Oversee deviations, CAPAs, change controls, and risk assessments related to commercial DP and FG manufacturing and packaging activities.
• Ensure QA oversight of continued process verification, ongoing validation, and lifecycle management for commercial DP and FG processes.
• Drive inspection readiness and lead QA support for regulatory inspections at CMOs, including routine, pre-approval, and for-cause inspections.
• Plan, perform, and follow up on audits of DP/FG CMOs and critical suppliers supporting commercial manufacturing and packaging.
• Provide QA input to regulatory submissions, variations, and post-approval changes related to DP and FG.
• Act as a key QA interface to Supply Chain and Distribution, proactively identifying and mitigating quality- and release-related risks impacting commercial supply.
• Contribute to continuous improvement of Genmab's Pharmaceutical Quality System with focus on commercial DP/FG operations and outsourced manufacturing.

• You hold a MSc degree or equivalent in life science.
• Minimum 10 years of experience within the pharmaceutical industry, with extensive GMP QA experience supporting commercial Drug Product and/or Finished Goods manufacturing at CMOs.
• Demonstrated experience with QA batch disposition and release in a commercial DP/FG environment.
• Proven experience building and scaling QA teams in response to business growth and increasing complexity.
• Strong understanding of sterile and/or non-sterile DP manufacturing, aseptic processing, packaging, labeling, and distribution activities.
• 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, GDP, and ICH requirements and post-approval lifecycle management.
• Comfortable operating in a high-complexity, supply-critical, and regulated environment.
• Excellent English communication skills and a pragmatic, risk-based QA mindset.

• A QA leadership role with direct accountability for quality and release of commercial Drug Product and Finished Goods.
• The opportunity to build and mature a scalable QA organization supporting a growing global commercial portfolio.
• A role combining long-term strategic ownership with hands-on QA decision-making in complex, supply-critical DP/FG operations.
• A collaborative, performance-driven culture that values quality, accountability, and continuous improvement.

• 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!