Associate Director PV QA

The role: R&D QA seeks an Associate Director for the PV QA team, an experienced GVP auditor focused on FDA and European GVP requirements. Lead QA inspections (unannounced and announced) and perform hands-on GVP QA activities, including audits and support to stakeholders across the company.

Responsibilities:
- Plan, conduct, report, and follow up on quality audits within GVP-regulated areas
- Mentor and onboard QA colleagues and Lead Auditors
- Develop and maintain audit strategies with the Director of PV QA and senior QA colleagues
- Review, contribute to, and approve SOPs and QMS documents
- Provide QA input to IT systems/digital solutions supporting clinical activities (with Digital QA)
- Manage and lead QA activities (risk assessments, deviation management, CAPA)
- Develop and deliver training for internal teams and external partners, as applicable
- Monitor regulatory updates, industry trends, and best practices to ensure ongoing compliance; develop tools to improve audit processes
- Lead inspection activities
- Participate in developing/maintaining/improving the Genmab Quality Management System (QMS)
- Contribute input to Quality Management Reviews, as applicable

Requirements:
- MSc in Natural Science (or similar) and at least 10 years’ experience auditing Pharmacovigilance activities
- Experienced Lead Auditor within GVP (preferred in-depth knowledge of outsourced and internal safety processes)
- Proficiency with/understanding of Veeva Vault QMS (advantage)
- Experience with due diligence and qualification of new vendors/services
- Recognized domain expert in GVP who can educate others

Benefits (U.S. candidates): $156,000–$234,000 salary band; 401(k) match, health/dental/vision, paid time off, parental leave, backup care/family support, commuter benefits, tuition reimbursement, and Lifestyle Spending Account.