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