Quality Leadership & Compliance
1. Ensure full compliance of site operations with EU GMP, US GMP, corporate quality standards, and internal policies.
2. Act as the site quality authority during regulatory inspections, audits, and interactions with health authorities.
3. Drive alignment between site practices, global procedures, and evolving regulatory expectations.
Quality Management System (QMS)
4. Lead, maintain, and continuously improve the Quality Management System (QMS) to support operational excellence.
5. Provide oversight of deviations, complaints, OOS, CAPAs, change control, and documentation systems, ensuring data integrity and timely closure.
6. Oversee the creation, routing, approval, and issuance of critical GMP documentation supporting all phases of product operations.
7. Lead coordination of customer change controls, ensuring approvals in line with quality agreements.
Performance, Risk & Continuous Improvement
8. Define, monitor, and analyze Quality KPIs, identifying trends and driving continuous improvement initiatives.
9.