Director, GCP Inspection Readiness & Management
$191,250–$247,500 year
On-site · Parsippany, New Jersey, United States
Job Summary
Lead GCP inspection readiness across R&D clinical trials; serve as the primary sponsor representative during regulatory inspections and provide strategic leadership to evolve global inspection management capabilities; develop and maintain GCP inspection readiness strategies, oversee TMF/eTMF readiness and vendor readiness (CROs, labs, eCOA, IRT); define KPIs, drive continuous improvement, training, and change management; collaborate across R&D Quality and vendor partners; strong knowledge of GCP, TMF/eTMF, and GxP Quality Management Systems; travel as needed.
Required Qualifications
- PharmD or PhD with 8+ years of relevant experience; OR MA/MS/MBA with 10+ years of relevant experience; OR BA/BS with 12+ years of relevant experience
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