Associate Director, Team Lead, QA GMP

TheRole

Genmab is seeking an experienced QA Associate Director for GMP QA Development Drug Product (DP) & Clinical Supply to provide strategic and operationalQAoversight of development manufacturing activitiesprimarily performedthrough external manufacturing partners.

Therole iscentralto ensuring product quality patient safety and reliableclinicalsupplyacrossa fully outsourced development manufacturing network.In close collaborationwith CMOs and cross-functional stakeholders you willhelp sustaina strong quality culture andensurecompliance with applicable GMP requirements throughout the development lifecycle.

Inthisroleyou willyour quality and leadershipexpertiseaspart of Genmabs global GMP QA organizationsupporting development programs and outsourcedDP and IMPmanufacturing activities.

The position is based in Denmark and reports to the Director of GMP QA Development Drug Product & ClinicalSupply.

Key Responsibilities

TheQA Associate Directorsresponsibilities will include:

• Lead coach and developateamof5to drivehigh performance engagement accountability and professional growth.

• Define teampriorities operational standards and ways of workingthat support collaboration compliance andinspectionreadiness.

• Build andmaintainstrongstakeholderrelationships toenabletimely compliantdelivery.

• Lead and contribute to cross-functional projects and strategic initiatives within the QAorganization.

• 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 DPClinical Supplymanufacturingand 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 Genmabs Pharmaceutical Quality System.

In this Associate Director role you will collaborate closely with the GMP QA team internal stakeholders across CMC Global Clinical Drug Supply and Regulatory Affairs as well as CMOs supporting DP and Clinical Supply activities. The position offers an opportunity to contribute to GMP QA development projects and Genmabs innovative product portfolio helping advance cancer therapy for patients.

WhatWeAreLookingFor

• 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 continuous development.

WhatYoullGain

• A QA leadership role with direct accountability for the quality and release of clinical Drug Product and Clinical Supply.

• A key position in a growing highly collaborative QA organization with broad cross-functional exposure.

• A role that combines long-term strategic ownership with hands-on QA decision-making in complex supply-criticalDPand Clinical Supply operations.

• The opportunity to support innovativebiologicsand development programs that can make a meaningful difference for patients.

• Close collaboration with experienced colleagues CMOs and global stakeholders across the value chain.

• A dynamic international work environment built on professionalism trust and continuous development.

• The chance to influence processes drive quality improvements and help shape ways of working in an evolving organization.

• A culture that values teamwork knowledge sharing and a positive environment where people support each other and succeed together.