Director of PV QA

Director of PV QA

Genmab

Copenhagen, Denmark

The Role

R&D QA is looking for a Director of PV QA that is already an experienced auditor within GVP, especially focusing on the European requirements. Furthermore, the Director of PV QA is an experienced leader of highly skilled team members or is highly motivated to become one.

The role includes hands on GVP QA activities such as support to our many stakeholders as well as performing audits alone or together with own team members or with support from neighboring teams. You will take the role as QA Inspection Lead at inspections or similar.

Besides offering your in-depth expertise within GVP you will be leading team members in the US as well as at the DK office. You become a key member of the R&D QA leadership team that together drives people engagement, setting strategies and ensuring R&D QA deliverables.

The role requires strong collaboration capabilities in an international setting across various QA departments as well across the company with target stakeholders such as GDS&PV, Medical Affairs, Clinical Operations and Commercial. In 2025 Genmab became MAH in EU hence PSMF deliverables and collaboration with the QPPV are essential.

Key responsibilities include

• Planning, performing and reporting quality audits within the GVP regulated areas;
• Lead PV inspections activities in connection with FDA, EMA or PMDA inspections;
• Provide leadership and oversight of PV QA and ensure timely, compliant and effective QA deliverables;
• Mentor on-boarding QA colleagues to increase the competency level across the global R&D QA team;
• Develop and maintain the PV QA strategies in collaboration with the R&D QA leadership team;
• Drive standardization, harmonization, and scalability of PV QA processes;
• Ensure compliance with global GxP standards, regulatory requirements, and Genmab Quality Systems;
• Lead quality improvement initiatives to enhance processes and procedures;
• Optimizing and executing due diligence activities and qualification of new vendors or services;
• Review and contribution to Standard Operating Procedures (SOPs) and approve QMS documents as applicable;
• Deliver input to IT systems/solutions used in clinical activities via directions from Digital QA;
• Manage and lead quality assurance activities, including risk assessment, deviation management, and Corrective and Preventive Actions (CAPA) processes;
• Develop and deliver training programs for internal teams and external partners, as applicable;
• Monitor industry trends, regulatory updates, and best practices to support the organization's quality standards are up to date;
• Participate in developing, maintaining, and improving the Genmab Quality Management System (QMS);
• Deliver input to the Quality Management Review, as applicable.

Requirements

• MS, or BS or similar in Natural Science;
• 15+ years of experience in a PV Quality function or similar with proved leadership experience or aspiration to do so;
• Experienced Lead Auditor within GVP;
• Deep expertise in GVP processes and the European requirements;
• Strong understanding of safety aspects in connection with clinical trials, market access programs, post marketing GVP requirements as well as global regulatory expectations;
• Demonstrated leadership in regulatory inspections and health authority interactions;
• Considered to be a Domain Expert within GVP by peers with a strong interest and ability to educate others.

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!