Global GCP Compliance Manager
2 weeks ago
Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT.
Job Title: Global GCP Compliance ManagerEstimated Salary: $120,000 - $180,000 per year
About the RoleWe are looking for an experienced professional to lead our GCP inspection readiness initiatives across various clinical study teams. The ideal candidate will have extensive experience in GCP-related QA functions and a proven track record of driving quality processes improvements.
Key Responsibilities- Supervise and manage activities for inspection readiness, leading inspections from regulatory authorities such as FDA, EMA, CFDI, MFDS, PMDA, TGA, etc.
- Collaborate with cross-functional teams to ensure unified approaches to inspection readiness strategies.
- Assign inspection requests to appropriate subject matter experts (SMEs) and provide guidance to ensure timely fulfillment.
- Develop and maintain QA systems, including investigations, deviations, CAPAs, and significant quality events (SQEs).
- Support and manage pre-inspection visits at investigative sites.
- Fulfill all inspection commitments, respond to inspections, and conduct post-inspection activities, CAPAs, and resolve issues for timely closure.
- At least 7-10 years of experience in GCP-related QA functions in the pharmaceutical, biotechnology, or related healthcare industries.
- Extensive understanding of international GCP requirements and standards in the pharmaceutical, medical device, and biotech industries.
- Proven ability to set strategies and drive initiatives for improving quality processes.
- Demonstrated leadership skills and ability to mentor others.
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