General Manager, Quality Assurance

Job Description

The position provides enterprise leadership for Quality Assurance (QA) governance, regulatory compliance, and Quality Management Systems (QMS) across pharmaceutical manufacturing operations, including combination products in alignment with applicable global regulations and standards. The role defines, implements, and continuously enhances quality policies, SOP frameworks, and inspection programs to ensure consistent delivery of safe, effective, and compliant products. It oversees QMS effectiveness, audit readiness, risk management, deviation and CAPA governance, vendor quality oversight, and data integrity systems. The incumbent drives SOP review and system upgradation initiatives to strengthen compliance and operational efficiency. Acting as a senior quality authority, the role partners with Manufacturing, QC, Validation, Supply Chain, and Regulatory teams to foster a strong quality culture, lifecycle quality management, and sustained global regulatory compliance while developing future QA leadership capability.

• Lead enterprise-wide Quality Assurance strategy, governance, and execution, ensuring alignment with global regulatory standards

• Ensure compliance with global cGMP requirements, including quality systems for combination products

• Oversee QMS implementation, monitoring effectiveness, and driving continuous improvement initiatives

• Govern Change Control, Deviation Management, Investigations, and CAPA systems to mitigate quality risks

• Drive audit and inspection readiness, including internal, vendor, customer, and regulatory inspections

• Review and approve batch documentation, product quality reviews, and batch disposition decisions

• Lead SOP review, revision, and system upgradation activities to maintain compliance and operational robustness

• Oversee supplier and vendor qualification, performance monitoring, and quality oversight programs

• Monitor quality metrics, trends, and risk indicators to proactively prevent compliance gaps

• Provide leadership during market actions, recalls, regulatory escalations, and crisis management scenarios

• Ensure data integrity, documentation control, and compliance across electronic quality systems

• Build and mentor high-performing QA teams, strengthening quality culture and succession planning

• Any Job assigned by the HOD

• To avoid/save/optimise the cost of the Quality operation

• To provide the developmental training

Education:

• MSc Chemistry

Experience:

• 20 years

Specialized Knowledge: Licenses:

Categories