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Clinical Quality Assurance Lead
3 days ago
This senior-level position reports directly to the Head of Global QA and is responsible for ensuring the quality and compliance of Investigational Medicinal Products (IMPs) across various markets. The ideal candidate will have extensive experience in pharmaceutical or biotech industries, with a strong understanding of GMP, GDP, and GCP regulations.
Main Responsibilities:
- Lead supplier management teams to maintain quality oversight of IMPs.
- Act as primary quality liaison for external suppliers, organizing inquiries, investigations, and audit follow-ups.
- Oversee batch record reviews and release for IMPs across US, EU, and RoW clinical trials.
- Monitor and manage key performance indicators (KPIs) related to IMP supplier quality.
- Ensure compliance with Quality Agreements and support revisions in collaboration with internal teams.
- Work cross-functionally with R&D, GCP/GVP QA, QA Supplier Managers, and Product Quality Leads to address and escalate IMP quality issues.
About You
You are a seasoned professional with a proven track record in quality assurance, particularly in the pharmaceutical or biotech sectors. Your expertise includes a deep understanding of regulatory requirements, excellent leadership skills, and the ability to foster open communication among cross-functional teams.
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