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.
Solid leadership, decision-making, and stakeholder management skills.
Ability to manage multiple sites and cross-functional teams.
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.
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 Valuable Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP).
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