Job Description
The Manager, IMP Quality Europe is responsible for ensuring compliance and quality oversight of Investigational Medicinal Products (IMPs) across internal and external operations in Europe. This role focuses on GxP compliance, deviation management, regulatory alignment, and cross-functional collaboration to uphold the highest quality standards for clinical trials and commercial distribution.
The ideal candidate will have deep expertise in IMP regulations, GMP/GDP, and EU legislative requirements , with a strong ability to lead investigations, drive corrective actions, and ensure seamless compliance across stakeholders.
Key Responsibilities
1. IMP Quality Oversight & Compliance
- Lead and troubleshoot quality investigations (e.g., temperature excursions, deviations, complaints) for IMPs at internal sites and external partners (CMO/CDMOs).
- Ensure thorough root-cause analysis (RCA) and corrective...
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