Role & responsibilities

Quality Assurance - Audit Compliance and Risk Management

- Experience 16+ years of experience in Pharmaceutical Quality, Compliance, Regulatory Affairs, Risk Management, or Quality Systems.
- Robust knowledge of FDA, Health Canada, EU GMP, MHRA, WHO, and other global regulatory requirements.
- Experience in manufacturing, quality operations, inspection management, and Data Integrity programs.
- Demonstrated leadership experience in regulated pharmaceutical environments.
- Audit Compliance & Risk Management is responsible for leading the organization's pharmaceutical compliance, regulatory governance, risk management, data integrity, and inspection readiness programs. The role ensures compliance with global health authority regulations, GxP requirements, corporate quality standards, and patient safety expectations while fostering a culture of quality and continuous improvement.

1. Compliance Management & Regulatory Oversight 2.



Enterprise Risk Management

3. Data Integrity Governance

4. Regulatory Inspection Readiness

5. Quality Systems Governance

6. Investigation & CAPA Oversight

7. Supplier & Third-Party Compliance

8. Training & Compliance Culture

- Professional certifications such as ASQ, RQAP, Six Sigma, ISO Lead Auditor, Compliance Certifications, or Risk Management Certifications are desirable.

Preferred candidate profile Core Competency expected in Pharmaceutical Compliance, Regulatory Governance, Enterprise Risk Management, Data Integrity (ALCOA+) , Quality Management Systems, GMP/GDP/GLP/GxP Compliance, Regulatory Inspection Management, CAPA & Investigation Excellence, Supplier Compliance, Quality Culture Development, Strategic Leadership, Stakeholder Management.

📌 Deputy General Manager Quality Assurance - Audit and Compliance (Bengaluru)
🏢 Apotex
📍 Bengaluru