Description
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 secure, 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 solid quality culture, lifecycle quality management, and sustained global regulatory compliance while developing future QA leadership capability.

Essential Functions




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 proact

📌 General Manager, Quality Assurance Kowdoor (India)
🏢 Amneal Pharmaceuticals
📍 India