Senior Director, Quality Control Lab

Senior Director, Quality Control Lab

Genmab

Ballerup, Denmark

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.

Quality Control Operations

• 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.

Quality and Compliance Oversight

• 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.

Leadership and People Development

• 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.

Cross-Functional Collaboration

• 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.

Requirements

• 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.

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!