Senior Director, Quality Control Lab.

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

The Senior Director, Quality Control provides enterprise-level strategic, scientific, and operational leadership for Genmab's QC activities, with a focus on internal capabilities that support the development, manufacturing, and commercialization of Genmab's portfolio.

This role is accountable for defining the vision, operating model, and multi-year strategy for internal QC to support Genmab's evolving pipeline and transition to a fully integrated, commercial-stage biotechnology company. The role will shape future QC capabilities, operating models, and capacity strategies as the organization continues to scale.

As a key member of the Quality leadership team, this individual will shape and build a future-ready QC organization, ensuring scalable, innovative, and inspection-ready capabilities that enable accelerated development, successful product launches, and robust lifecycle management.

The role combines strategic leadership and transformation with oversight of QC operations, positioning QC as a critical business enabler through digitalization, advanced analytics, and modern analytical technologies.

Responsibilities

Strategic and Functional Leadership

• Define and drive a comprehensive 3-5 year QC strategy, including capability build, organizational design, and investment prioritization aligned with Genmab's portfolio and commercial ambitions.
• Establish a future-state vision for QC at Genmab, incorporating digital laboratories, automation, advanced analytics, and innovative analytical technologies.
• Lead the evolution of the QC operating model from a development-focused organization to a scalable, commercial-ready function.
• Contribute to defining the future QC footprint and capacity strategy, aligned with pipeline and commercial growth.
• Drive standardization, harmonization, and scalability of QC processes across programs and products.
• Lead the digital and data strategy for QC, including the development of an integrated LIMS/ELN ecosystem and advanced analytics capabilities to enable a scalable, data-driven QC function.
• Act as a strategic advisor to senior leadership on QC-related risks and opportunities impacting development and commercialization.

• Provide leadership and oversight of internal QC laboratory operations.
• Ensure timely, compliant, and reliable testing to support clinical and commercial product release.
• Ensure effective execution of stability programs, method transfers, validations, and lifecycle management.

• Ensure compliance with global GxP standards, regulatory requirements, and Genmab Quality Systems.
• Oversee investigations of deviations, OOS/OOT results, and laboratory events, ensuring robust root cause analysis and CAPA.
• Lead inspection strategy and readiness, serving as a key representative during health authority inspections and audits.
• Promote a culture of quality excellence, accountability, and continuous improvement.

• Build, lead, and develop a high-performing QC organization, aligned with Genmab's growth trajectory.
• Define organizational structure, capabilities, and talent strategy to support future needs.
• Drive succession planning, leadership development, and capability building within the QC function.
• Foster a culture of scientific rigor, collaboration, innovation, and accountability.

• Partner with Analytical Development, Manufacturing, QA, and Regulatory Affairs to ensure aligned control strategies and seamless product lifecycle execution.
• Support CMC regulatory submissions and health authority interactions.
• Collaborate with external partners, including CDMOs, CROs, and vendors, ensuring alignment with Genmab standards.
• Represent Genmab externally in industry forums and regulatory discussions, as appropriate.

• PhD, MS, or BS in Biochemistry, Analytical Chemistry, Biotechnology, or related life science discipline.
• 15+ years of experience in biopharmaceutical or biologics Quality Control or Analytical Sciences, with significant leadership experience.
• Proven track record of building, scaling, or transforming QC organizations, ideally supporting late-stage and commercial biologics.
• Deep expertise in biologics analytical testing (e.g., HPLC/UPLC, CE-SDS, ELISA, bioassays, identity, impurities).
• Strong understanding of GMP manufacturing, analytical lifecycle management, and global regulatory expectations.
• Experience defining and implementing QC strategies and operating models, with exposure to external network approaches.
• Demonstrated leadership in regulatory inspections and health authority interactions.
• Experience driving digitalization and data integrity initiatives (e.g., LIMS, ELN, data platforms).
• Strong business acumen with the ability to link QC strategy to pipeline progression and commercial success.

• 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!