Corporate Quality Assurance (Sr Manager/AGM)

Corporate QA initiatives

strategic corporate role

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.