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 Commercial. In2025 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