General Manager Quality Assurance

Navlakha Management Services; Mumbai; On-site; INR 900,000 - 1,800,000; Full time

Job summary

Navlakha Management Services seeks a senior Quality Assurance leader for the Paithan facility to drive QA strategy and regulatory compliance.

You will establish and maintain QMS, oversee deviations, CAPA, change control, OOS/OOT investigations, and lead audits and inspections in regulated markets, including US FDA and international authorities. A strong leader with robust communication skills is essential.

Qualifications

• M.Pharm/B.Pharm/M.Sc. in a relevant discipline.
• 15–20+ years of QA experience in pharmaceutical manufacturing.
• Strong experience in regulated markets (US and international).
• Proven experience handling USFDA and other regulatory inspections.
• Strong knowledge of cGMP, ICH, QMS and regulatory compliance.
• Experience leading large QA teams in a formulation/manufacturing plant.
• Strong leadership, analytical, investigation and decision-making skills.
• Excellent stakeholder management and communication skills.

Responsibilities

• Lead the Quality Assurance function for the Paithan facility.
• Ensure compliance with USFDA, WHO-GMP, EU-GMP, MHRA and other 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 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 quality-driven culture.
• Ensure timely closure of quality events and sustained CAPA.
• Support NPI, process validation, cleaning validation and technology-transfer activities.
• Provide strategic inputs to Plant Management and Corporate Quality.

Skills

Regulatory compliance

Quality management

Audit management

Leadership

Data integrity

QA strategy

Stakeholder management

Analytical skills

Education

M.Pharm

B.Pharm

M.Sc.

Job description

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