General Manager Quality Assurance

Key Responsibilities

• Lead the Quality Assurance function for the Paithan manufacturing facility.
• Ensure compliance with USFDA, WHO-GMP, EU-GMP, MHRA and other applicable regulatory requirements.
• Establish and maintain effective Quality Management Systems (QMS).
• Oversee deviations, CAPA, change control, OOS/OOT, investigations and risk management.
• Ensure timely review and approval of BMR/BPR, SOPs, specifications and other quality documents.
• Lead internal audits, vendor audits and regulatory inspections.
• Drive inspection readiness and ensure effective management of regulatory observations and commitments.
• Ensure compliance with Data Integrity and ALCOA+ principles.
• Collaborate with Production, QC, Engineering, R&D, Regulatory Affairs and Supply Chain teams.
• Monitor quality metrics and identify opportunities for continuous improvement.
• Develop and mentor the QA team and build a strong quality-driven culture.
• Ensure timely closure of quality events and implementation of sustainable CAPA.
• Support new product introduction, process validation, cleaning validation and technology-transfer activities.
• Provide strategic inputs to Plant Management and Corporate Quality on quality-related matters.

Candidate Profile

• Qualification: M.Pharm / B.Pharm / M.Sc. in a relevant discipline.
• Experience: 1520+ years of relevant experience in Quality Assurance within the pharmaceutical manufacturing industry.
• Strong experience in regulated markets, particularly US and other international markets.
• Proven experience in handling USFDA and other regulatory inspections.
• Strong knowledge of cGMP, ICH guidelines, QMS and regulatory compliance.
• Experience in leading large QA teams in a formulation/manufacturing plant.
• Strong leadership, analytical, investigation and decision-making skills.
• Excellent stakeholder management and communication skills.

Key Competencies

Regulatory Compliance | Quality Systems | USFDA Inspection Management | QMS | Data Integrity | Deviation & CAPA | Change Control | Risk Management | Audit Management | Team Leadership | Continuous Improvement