Executive – Corporate Quality Assurance

About the role

We are seeking a dynamic Executive (or Senior Executive) to lead our Corporate Quality Assurance function. The role will drive the implementation and harmonisation of Quality Management Systems across multiple manufacturing sites, ensure regulatory compliance and support audit readiness.

Key responsibilities

• Drive harmonisation and implementation of QMS across all manufacturing sites.
• Prepare, review and implement SOPs for QMS, validation, qualification, change control, CAPA, and training management.
• Conduct and coordinate periodic self‑inspections and internal audits, ensuring timely closure of observations.
• Manage market complaints, product recall activities and associated investigations.
• Review and monitor change controls, deviations, OOS/OOT, CAPAs and other quality system elements.
• Lead root‑cause analysis and ensure effective CAPA implementation across sites.
• Coordinate with Manufacturing, R&D, Regulatory Affairs and other functions for new product development and technology transfer.
• Support implementation and management of SAP, ERP, eQMS and other digital quality systems.
• Manage GMP and quality training programmes, delivering sessions and ensuring compliance.
• Support and lead regulatory inspections, customer audits and internal audits while maintaining continuous audit readiness.

Required profile

• B.Pharm / M.Pharm / M.Sc. in Chemistry, Microbiology, Biotechnology or related life sciences.
• 5‑10 years of experience in corporate quality assurance or quality systems within the pharmaceutical industry.
• Exposure to regulated markets such as USFDA, EU GMP, MHRA, WHO‑GMP or PIC/S is preferred.
• Strong knowledge of cGMP, GDP, ICH guidelines, data integrity and pharmaceutical quality systems.
• Hands‑on experience with CAPA, change control, deviations, OOS/OOT, risk management, validation and documentation.
• Experience handling regulatory inspections and customer audits.
• Excellent analytical, investigative, communication and stakeholder management skills.

Required skills

• SAP
• ERP
• eQMS