Associate Director, Inspection Readiness

Genmab

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Role summary

Associate Director role supporting clinical trial operations by establishing inspection readiness frameworks, ensuring compliance standards, and leading quality event oversight. Reports to Clinical Trial Operations and collaborates across functions to maintain regulatory compliance throughout trial lifecycles.

Where this listing comes from

This listing was compiled by RoleLantern from the employer's publicly available posting on Phenom, captured and rephrased by RoleLantern using automated (AI) tools on 2026-10-03 (originally posted 2026-10-03). It was not submitted or confirmed by the employer through RoleLantern. Details may be inaccurate, incomplete, outdated, or no longer available; please confirm with the employer's official posting before applying.

What they're looking for

Master's degree in Life Sciences, Pharmacy, Medicine, or related discipline
Minimum 10 years clinical operations, quality, inspection readiness, or compliance experience in pharma/biotech
Strong knowledge of ICH-GCP, clinical trial processes, and drug development lifecycle
Project management skills and process development experience
Risk identification and issue resolution capabilities
Cross-functional stakeholder management and collaboration in matrix organizations
Mentoring and colleague development experience

What you'll be doing

Establish and maintain inspection readiness frameworks for clinical trial teams across trial lifecycles
Design tools and processes leveraging digitalization to optimize inspection readiness and compliance
Lead investigations of non-compliances and quality events with closure follow-up
Conduct continuous inspection readiness assessments and generate actionable insights from metrics
Develop GCP training and lead inspection preparation as Control Room Lead during regulatory inspections

Compensation$156,000-$234,000 base

Privacy & handoff

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Date posted1 day ago

Last source checkToday

Salary listedNeeds clarity

Location clearNeeds clarity

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