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The Quality Assurance Manager is responsible for ensuring that all products and processes meet regulatory requirements. This involves overseeing the implementation of GxP procedures, managing quality systems indicators, and identifying compliance gaps.
- Main Responsibilities:
- Act as Sanitary Responsible Deputy Person for Gilead Sciences Mexico.
- Serve as QA subject matter expert in external audits.
- Manage business strategies regarding product distribution, testing, and release.
- Oversee GMP suppliers and Gilead's Mexico Warehouse Quality System to ensure GMP and GDP compliance.
- CAPA management.
- Change Control process implementation.
- Internal and External Deviations management.
- Complaints management.