Head – Quality Assurance

About the Role

Looking for an experienced Head – Quality Assurance (QA) at AGM/DGM level with strong experience in pharmaceutical formulations, particularly Oral Solid Dosage (OSD).

The candidate will be responsible for leading the site's Quality Assurance function, ensuring compliance with cGMP, regulatory requirements, quality systems, and international regulatory expectations. The role requires significant experience in handling regulatory inspections and audits from major international health authorities. Experience with Nutraceuticals will be an added advantage.

Key Responsibilities

• Lead the overall Quality Assurance function for the pharmaceutical formulation/OSD facility.
• Establish, implement, and maintain robust Quality Management Systems (QMS) in compliance with applicable GMP and regulatory requirements.
• Provide strategic and operational leadership to the QA team at the site.
• Ensure compliance with US FDA, MHRA, TGA, ANVISA, EU GMP and other applicable regulatory requirements.
• Lead preparation, coordination, and management of regulatory inspections and customer audits.
• Ensure timely investigation, response, CAPA implementation, and closure of audit/inspection observations.
• Oversee deviations, OOS/OOT, CAPA, change controls, complaints, product quality reviews, risk assessments, and investigations.
• Ensure effective implementation and continuous improvement of the site's QMS.
• Review and approve quality-related documents, procedures, protocols, reports, specifications, validation documents, and other controlled documents as applicable.
• Provide QA oversight for manufacturing, packaging, validation, technology transfer, qualification, and other GMP activities.
• Ensure appropriate batch release and compliance with approved specifications and regulatory requirements.
• Drive quality culture and GMP awareness across the organization, maintain continuous inspection readiness, and track changes in applicable regulations/guidelines.
• Interface with Regulatory Affairs, R&D, Manufacturing, QC, Engineering, Supply Chain, and senior management on quality and compliance matters.
• Lead and mentor the QA team, including succession planning and capability development.
• Identify quality risks and drive continuous improvement and compliance excellence across the site.
• Be responsible for data integrity across QA, QC, manufacturing, and computerized systems, with experience in ALCOA+ principles and electronic records/audit trails.

Qualifications & Experience

• M. Pharm.
• 20+ years of relevant experience in Pharmaceutical Quality Assurance.
• Strong experience in pharmaceutical formulations, particularly Oral Solid Dosage (OSD).
• Experience in leading site Quality Assurance functions and robust Quality Management Systems.
• Significant experience handling regulatory inspections and audits from major international health authorities.
• Experience with Nutraceuticals will be an added advantage.

Skills & Competencies

• The candidate must have handled at least 3 regulatory audits from USFDA/MHRA/EDQM/TGA/ANVISA within the last 3 years. At least 1 audit must have been conducted within the last 1 year.
• Quality Assurance & QMS leadership.
• US FDA / MHRA / EU GMP / TGA / ANVISA compliance.
• Deviation, OOS/OOT, CAPA and change-control management.
• Risk management.
• Root-cause analysis and problem solving.
• Quality metrics, management review and continuous improvement.
• Team leadership and people development.
• Excellent communication and documentation skills.