Director of PV QA

At Genmab we are dedicated to building extranotordinary 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

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.

Theroleincludes hands on GVP QA activitiessuch as support to our many stakeholders as well asperforming auditsalone ortogether with own team members or with support willtake the role as QA Inspection Lead atinspections or similar.

Besidesoffering yourin-depth expertise within GVPyou will be leading team membersinthe US as well asatthe DK office. You become a key member of the R&D QA leadership teamthat together drives people engagementsettingstrategiesand ensuringR&D QA deliverables.

Therole requires strong collaboration capabilities in an international settingacross various QA departments as wellacross the company withtargetstakeholderssuch asGDS&PV Medical Affairs Clinical 2025 Genmab became MAH in EU hencePSMFdeliverables and collaboration with the QPPVareessential.

Key responsibilities include:

• Planning performingandreportingquality audits within the GVP regulated areas

• LeadPV inspectionsactivities in connection withFDA EMA or PMDA inspections

• Provide leadership and oversight ofPV QA and ensure timely compliant and effective QA deliverables

• Mentor on-boarding QA colleagues to increase the competency level acrossthe globalR&DQAteam

• Develop and maintain thePV QAstrategies in collaboration with theR&D QA leadership team

• Drive standardization harmonization and scalability ofPV QAprocesses

• Ensure compliance with globalGxPstandards regulatory requirements and Genmab Quality Systems

• Lead quality improvement initiatives to enhance processes and procedures.

• Optimizingandexecutingdue diligenceactivitiesand qualification of new vendors or services

• Review and contribution to Standard Operating Procedures (SOPs) and approve QMS documentsas 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 organizations 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 BSor similar inNatural Science

• 15 years of experiencein a PV Quality function orsimilarwithprovedleadership experienceor aspiration to do so.

• Experienced Lead Auditor within GVP

• Deep expertise inGVP processes and the European requirements.

• Strong understanding ofsafety aspects in connection with clinical trials market access programs post marketing GVP requirements as well asglobal 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!

Locations

Genmab maximizes the efficiency of an agile working environment when possible for the betterment of employee work-life balance. Our offices are crafted as open community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether youre in one of our office spaces or working remotely we thrive on connecting with each other to innovate.

About Genmab

Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years its hard-working innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational quantitative and data sciences resulting in a proprietary pipeline including bispecific T-cell engagers antibody-drug conjugates next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030 Genmabs vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines.

Established in 1999 Genmab is headquartered in Copenhagen Denmark with international presence across North America Europe and Asia Pacific. For more information please visit and follow us on LinkedIn and X.

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