Job Description
I'm partnering with a leading multinational healthcare organization to appoint a Regional GCP Auditor to join its APAC Quality function. Reporting into a global R&D Quality leadership team, this position offers the opportunity to play a key role in strengthening clinical quality, inspection readiness, and GCP compliance across multinational clinical development programmes.
In this role, you will:
- Lead and execute GCP audits across investigator sites, Contract Research Organizations (CROs), vendors, E-system providers and Ethics Committees throughout the APAC region.
- Assess compliance with global GCP regulations including ICH E6, 21 CFR requirements and international clinical research standards, ensuring the integrity of clinical trial data and patient safety.
- Prepare comprehensive audit reports, perform risk assessments, identify compliance trends, and partner with cross-functional stakeholders to drive effective CAPA and contin...
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