Canada

Lead Inspection Management at Regeneron, West Durham Regional Municipality (Sunderland)

Lead Inspection Management at Regeneron, West Durham Regional Municipality (Sunderland)
Description
Take charge of GCP and compliance as an Associate Director in Regeneron's Global Development Quality Inspection Management. Engage with stakeholders and lead preparation activities across clinical trials.

In this strategic leadership role, you will be responsible for managing GCP, GVP, and GLP inspections while liaising with Clinical Study teams. Your expertise will lead inspection management processes and prepare teams for successful regulatory inspections. You will identify potential issues and collaborate on solutions to ensure inspection success.

Key Responsibilities:• Manage notifications of upcoming regulatory inspections • Prepare and integrate inspection management processes • Provide consultancy and support to Clinical Study teams • Conduct mock inspections and training sessions • Lead activities during regulatory inspections

Requirements:• Bachelor's degree with 10+ years in healthcare/pharma • Experience in quality/compliance or Clinical Development • Advanced knowledge of GCP and GVP guidelines • Proven ability to train and manage teams • Strong interpersonal and stakeholder engagement skills

Lead GCP inspection strategies and enhance quality compliance at Regeneron. #J-18808-Ljbffr
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