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Corporate Quality Assurance (Sr Manager / AGM)

Corporate Quality Assurance (Sr Manager / AGM)

RESONACLEMumbai, Maharashtra, India
1 day ago
Job description

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.
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