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

- Strong 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 Valuable 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-specification (OOS) investigations.
- Data Integrity & Validation: Oversee equipment qualification, cleaning validation, and computer system validation (CSV) in line with data integrity principles.

4. Cross-functional Leadership

- Partner with Manufacturing, R&D;, Supply chain management (SCM), Regulatory and Corporate teams to resolve quality issues.
- Provide guidance on product quality, technical issues, and compliance risks.
- Drive harmonization of quality standards across all plants.

5. Team Management & Capability Building

- Develop competency-building programs, training modules, and quality culture initiatives.
- Standardization: Align local site procedures with global quality standards and corporate policies.

Key Qualifications

- Education: B.Pharm / M.Pharm or M.Sc. in Chemistry.
- Experience: 10 - 14+ years of relevant experience in Pharmaceutical QA/QC, preferably with significant experience in Corporate QA, Quality Assurance, or a multi-site quality management role.
- Experience in leading or managing QA teams is essential.
- Strong exposure to API manufacturing and pharmaceutical quality systems.
- Experience with regulated markets and global regulatory inspections.
- Strong knowledge of cGMP, QMS, Data Integrity, risk assessment, audits, CAPA, deviations, change controls and OOS investigations.
- Good understanding of regulatory requirements including USFDA, PMDA, EU, WHO and ANVISA.
- Exposure to laboratory IT systems, validation and CSV will be an advantage.

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