Associate Director PV QA

Genmab • Princeton, TX

3d • Hybrid

About The Position

At Genmab, we are dedicated to building extra[not]ordinary® 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 an Associate Director to the PV QA team that is an experienced auditor within GVP, especially focusing on the FDA and European GVP requirements. Your in-depth GVP experience enables you to train other auditors within GVP and support our stakeholders in complex quality issues. Furthermore, you will take up the QA inspection lead role during PV inspections unannounced as well as announced. 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 team members of neighboring teams. Besides offering your in-depth and strong scientific expertise within quality assurance and all the GVP regulatory requirements you will become member of a PV QA team of highly skilled and motivated team members located at the Princeton office as well as the office in Denmark. The role requires strong collaboration capabilities in an international setting both across various QA departments as well as 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.

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 preferrable in-death 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 as Domain Expert within GVP by peers and has a strong interest and ability to educate others

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.
• Mentoring on-boarding QA colleagues as well as experienced Lead auditors to increase the competency level across R&D QA.
• Lead inspections activities
• Participate in developing, maintaining, and continuously improving the Genmab Quality Management System (QMS)
• Contribute input to Quality Management Reviews, as applicable

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior