We are looking for an experienced Corporate Quality Assurance (CQA) Manager to drive quality systems, compliance, regulatory readiness, and quality governance across multiple API manufacturing and job-work facilities.

The role will be responsible for ensuring alignment of site QA teams with corporate quality standards and global regulatory requirements, while driving continuous improvement and a strong quality culture across the organization.

Key Responsibilities
- Solid understanding of QMS, Data Integrity, and regulatory guidelines.
- Excellent audit handling and documentation review capability.
- Strong leadership, decision-making, and stakeholder management skills.
- Ability to manage multiple sites and cross-functional teams.

1. Corporate Quality Leadership
- Drive corporate quality strategy across API & Job work facilities.
- Ensure alignment of site QA teams with global quality standards and corporate quality policies.
- Oversee implementation and enhancement of QMS across all units.

2. Compliance & Regulatory Management
- Audit Readiness:



Support and coordinate internal, customer, and external regulatory inspections (such as USFDA or WHO).
- Ensure compliance with USFDA, PMDA, EU, WHO, ANVISA and other global regulatory requirements.
- Lead readiness and support for regulatory audits and customer inspections across sites.
- Review and approve quality documents, SOPs, investigation reports, CAPAs, change controls, deviations, etc.
- Ensure adherence to current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP).

3. Quality Oversight & Governance
- Conduct corporate quality audits for manufacturing sites and third-party units.
- Monitor key quality metrics and drive continuous improvement initiatives.
- Ensure robust data integrity practices across all quality and manufacturing operations.
- Quality Management Systems (QMS): Manage and track deviations, Corrective and Preventive Actions (CAPA), change controls, and out-of-specificatio

📌 Corporate Quality Assurance Manager (Mumbai)
🏢 BEC Chemicals
📍 Mumbai