Associate Director PV QA
Genmab · Princeton, New Jersey ·
- Employment
- Contract
- Category
- QA
- Experience
- 25+ years
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.
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 You will 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.
You will 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 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
For US based candidates, the proposed salary band for this position is as follows:
$156.000,00---$234.000,00The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.
When you join Genmab, you’re joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for:
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!
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 you’re 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, Genmab’s 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 Genmab.com and follow us on LinkedIn and X.
Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).
Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.