Associate Director PV QA

About the Role R&D QA is looking for an Associate Director to the PV QA team. As an experienced auditor within GVP, especially focusing on FDA and European GVP requirements, you will train other auditors and support our stakeholders in complex quality issues. You will take the QA inspection lead role during PV inspections, both unannounced and announced. You will support stakeholders across QA departments, Medical Affairs, Clinical Operations, and Commercial, and collaborate with the QPPV for PSMF deliverables. Responsibilities Plan, conduct, report, and follow up on quality audits within GVP-regulated areas Mentor and onboard QA colleagues and experienced Lead Auditors to strengthen capabilities across the global R&D QA department Develop and maintain audit strategies in collaboration with the Director of PV QA and other senior QA colleagues Review, contribute to, and approve SOPs and QMS documents Provide QA input to IT systems and digital solutions supporting clinical activities, in collaboration with Digital QA Manage and lead QA activities, including risk assessments, deviation management, and CAPA processes 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 and facilitate the audit processes Lead inspections activities Participate in developing, maintaining, and continuously 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 of profound experience within auditing of Pharmacovigilance activities Experienced Lead Auditor within GVP; preference for in-depth knowledge related to outsourced safety processes and internal safety processes Proficiency in the use and understanding of Veeva Vault QMS will be an advantage Experience with the due diligence process and qualification of new vendors or services Considered a Domain Expert within GVP by peers and has a strong interest and ability to educate others Compensation For US-based candidates, the proposed salary band is $156,000—$234,000. The actual offer will consider factors such as skills, qualifications, experience, and location. Additional forms of compensation, such as discretionary bonuses and long‑term incentives, may apply. Benefits 401(k) Plan: 100% match on the first 6% of contributions Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance Voluntary Plans: Critical illness, accident, and hospital indemnity insurance Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well‑being support Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses 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 #J-18808-Ljbffr