Corporate Quality Assurance Manager

BEC Chemicals; Mumbai; On-site; INR 1,500,000 - 3,000,000; Full time

Job summary

BEC Chemicals seeks an experienced Corporate Quality Assurance (CQA) Manager to drive quality systems and governance across API manufacturing and job-work facilities.

You will align site QA teams with corporate standards and global regulatory requirements, fostering continuous improvement and a strong quality culture across the organization.

Qualifications

• Bachelor or higher in pharmaceutical science with QA experience.
• 10–14+ years in Pharmaceutical QA/QC roles.
• Leading or managing QA teams is essential.
• Experience with API manufacturing and pharma quality systems.
• Familiarity with global regulatory inspections (USFDA, PMDA, EU, WHO, ANVISA).

Responsibilities

• Drive corporate quality leadership across API and Job Work facilities.
• Ensure alignment of site QA with global quality standards and corporate policies.
• Oversee QA documentation, CAPA, deviations, and change controls.
• Coordinate internal, customer, and regulatory audits and inspections.
• Promote data integrity and robust QMS across sites.

Skills

QMS

Data Integrity

Regulatory Compliance

Auditing

QA Leadership

cGMP

US FDA

CSV Validation

Education

B.Pharm / M.Pharm

M.Sc in Chemistry

Tools

LIMS

Audit Management System

CSV Validation Tools

Job description

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 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-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.