Associate Director PV QA
Job Location:
Princeton, NJ - USA
Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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 an AssociateDirector to the PV QA team that is an experienced auditor within GVP especially focusing on theFDA andEuropean GVPrequirements.Yourin-depthGVP experienceenables you totrain other auditors withinGVPand support our stakeholders in complex quality issues.Furthermore youwilltake uptheQA inspectionleadrole during PV inspections unannounced as well as announced.
The role includes hands on GVP QAactivitiessuch 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 yourin-depthand strong scientific expertise within quality assurance and allthe GVPregulatory requirementsyou will become member of a PV QA team of highly skilled and motivated team memberslocated 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 departmentsaswell as across the company with target stakeholders such as GDS&PV Medical Affairs Clinical Operations and 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 globalR&D QAdepartment
Develop and maintain audit strategies in collaboration with theDirector of PV QAand 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 complianceYou 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 acrossR&D QA.
You willlead 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 orsimilar and at least10years ofprofoundexperience withinauditing of Pharmacovigilance activities
Experienced Lead Auditor withinGVPpreferrablein-death knowledge related tooutsourced safety processes and internal safety processes.
Proficiency in the use and understanding of Veeva Vault QMSwill be anadvantage
Experience withthe due diligence process and qualification of new vendors or services
Considered as Domain Expert withinGVPby peers and has a strong interest and ability to educateothers
For US based candidates the proposed salary band for this position is as follows:
$156.00000---$234.00000The 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 youre 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 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.
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 ().
Please note that if you are applying for a position in the Netherlands Genmabs 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.
Required Experience:
Director
About Company
Founded in 1999, we are an international biotech company committed to improving the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, our passionate, innovative and collaborative team has invented next-generation antibody technology platforms ... View more
