We are seeking a highly experienced Quality Assurance leader to drive Corporate QA initiatives across multiple formulation manufacturing sites. The incumbent will be responsible for strengthening the company’s Audit, Compliance, and Validation / Qualification (VQ) framework, ensuring adherence to global regulatory standards, and maintaining continuous inspection readiness .
This is a strategic corporate role requiring 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.