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Associate Director, Inspection Readiness

Genmab
October 2, 2026
Full-time
Remote friendly (Princeton, NJ)
Worldwide
Clinical Research and Development
Role: Associate Director, Inspection Readiness, supporting clinical trial operations by ensuring compliance and inspection preparedness across trials and service providers. Responsibilities: establish and maintain inspection frameworks, optimize digital tools, lead investigations of non-compliances, drive continuous assessment and improvement of trial readiness, develop inspection training, support GCP inspections as Control Room Lead, and oversee quality events and compliance in clinical operations. Requirements: MSc in Life Sciences, Pharmacy, Medicine, or related; 10+ years in clinical operations, quality, or compliance within pharma/biotech; strong knowledge of GCP, regulations (FDA, EMA, etc.), and clinical trial processes; project management and stakeholder engagement skills; experience in process/system development and mentoring. High-Value: clinical compliance, inspection readiness, GCP, quality oversight, global and cross-functional coordination, regulatory adherence, trial lifecycle. WorkSetup: not specified; likely hybrid or remote, given the global scope.