Corporate Quality Assurance (Sr Manager/AGM)

As a highly experienced Quality Assurance leader, you will drive Corporate QA initiatives across multiple formulation manufacturing sites. Your primary responsibility will be to strengthen the company's Audit, Compliance, and Validation/Qualification (VQ) framework, ensuring adherence to global regulatory standards, and maintaining continuous inspection readiness. This strategic corporate role requires close coordination with site QA, manufacturing, and regulatory teams to uphold a consistent culture of quality excellence and compliance across all units. Key Responsibilities: - Lead and manage internal and external audits across formulation sites (OSD, Injectables, Topicals). - Ensure full compliance with USFDA, MHRA, EU, ANVISA, TGA, and WHO regulatory requirements. - Oversee audit preparedness, inspection readiness, and CAPA effectiveness. - Develop and implement corporate QA policies, SOPs, and governance frameworks. - Review and monitor site-level quality metrics and compliance dashboards. - Collaborate with site QA teams to standardize systems and close quality gaps. - Review and approve validation protocols, change controls, deviations, and risk assessments. - Ensure alignment of VQ activities with GMP, ICH, and data integrity requirements. - Design and deliver training programs on compliance, audit management, and regulatory awareness. - Act as a corporate liaison during regulatory inspections and manage post-inspection communications. Key Requirements: - Education: B.Pharm / M.Pharm / M.Sc. (Life Sciences) or equivalent. - Experience: 15+ years in Corporate QA within the pharmaceutical formulations industry. - Proven exposure to global regulatory audits (USFDA, EU, MHRA, ANVISA, TGA). - Strong understanding of GMP, ICH, QMS, and data integrity principles. - Hands-on experience with CAPA systems, documentation review, and validation oversight. - Excellent leadership, communication, and stakeholder management skills. - Ability to travel to multiple manufacturing sites as required.,