GM/DGM - QA

Role & responsibilities

• M.Pharm / B.Pharm / M.Sc. with 20+ years of rich experience in Quality Assurance within sterile pharmaceutical manufacturing.
• Minimum 8 years in a senior leadership role handling site-wide QA operations for sterile injectable facilities.
• Extensive experience in sterile oncology products catering to regulated markets.
• Demonstrated expertise in successfully handling and hosting global regulatory inspections and customer audits, including USFDA, EMA, MHRA, ANVISA, WHO-GMP, PIC/S, and other international agencies.
• Proven track record in establishing and maintaining robust quality systems, sterility assurance programs, and inspection readiness culture.
• Strong exposure to aseptic processing, Annex 1 implementation, Contamination Control Strategy (CCS), data integrity, and quality risk management.
• Experience in setting up and leading QA organizations for new or expanding sterile facilities will be preferred.
• Excellent leadership, stakeholder management, communication, and team-building capabilities.

Preferred candidate profile

• Regulatory Inspection Management & Audit Readiness
• Global GMP Compliance
• Sterility Assurance & Aseptic Operations
• Quality Systems Excellence
• Data Integrity & Quality Risk Management
• Leadership & Team Development
• Strategic Planning & Cross-functional Collaboration