Quality Assurance Manager

Job Summary:

We are seeking a highly experienced and meticulous Senior Quality Assurance Manager to serve as a critical "Gatekeeper" for our Quality Management System (QMS) and regulatory compliance framework. This individual will be the primary authority responsible for ensuring unwavering adherence to internal processes and external regulatory requirements across GxP-regulated activities, particularly those involving Computerized Systems. The successful candidate will possess deep expertise in global regulations (including FDA 21 CFR Part 11, EU Annex 11, GxP/GCP, CDSCO, PMDA, TGA, WHO GMP), industry best practices (GAMP 5, ISO 9001), and possess the authority and communication skills to enforce standards, guide teams, manage audits, and champion a robust quality culture throughout the organization. This role is pivotal in safeguarding data integrity, ensuring product quality, and maintaining inspection readiness.

Key Responsibilities:

1. QMS & Process Adherence Gatekeeper

2. Regulatory Compliance Oversight:

3. Audit Management & Response:

4. CAPA Management:

5. Computer System Validation (CSV) & Data Integrity:

6. Change Management & Documentation:

7. Vendor & Supplier Quality:

8. Training & Mentorship: