Role & responsibilities
Lead and harmonize Corporate Quality Management Systems (QMS) across manufacturing sites.
Drive compliance with cGMP, ICH Guidelines, Data Integrity, and global regulatory requirements.
Oversee Quality Systems including Change Control, Deviations, CAPA, OOS/OOT, Validation, Qualification, Risk Management, Market Complaints, and Product Recall.
Lead regulatory inspections (USFDA, MHRA, EU GMP, WHO-GMP, etc.), customer audits, and ensure continuous inspection readiness.
Provide strategic oversight for critical investigations, CAPA effectiveness, and quality risk management.
Drive technology transfer activities between R&D;, manufacturing sites, and third-party manufacturers.
Lead vendor qualification and third-party audits.
Review and approve corporate quality documents, SOPs, MFC/MPC, PDRs, and other quality system documentation.
Partner with Manufacturing, R&D;, Regulatory Affairs, Engineering,



and Supply Chain to strengthen quality and compliance.
Lead quality digitalization initiatives, including SAP, ERP, and eQMS platforms.
Build and mentor high-performing Quality teams while fostering a culture of compliance and continuous improvement.

Preferred candidate profile
B.Pharm / M.Pharm / M.Sc. or equivalent qualification.
1525 years of experience in Pharmaceutical Quality Assurance, with significant exposure to Corporate Quality Assurance.
Solid experience handling global regulatory inspections and audits.
Thorough knowledge of Quality Management Systems, Data Integrity, cGMP, ICH Guidelines, and regulatory expectations.
Demonstrated leadership in managing multi-site quality operations and cross-functional teams.
Excellent communication, stakeholder management, and strategic leadership skills.

📌 General Manager Corporate Quality Assurance Mumbai
🏢 Aristo pharmaceuticals
📍 Mumbai