Senior Manager – In-Process Quality Assurance (IPQA)

About the role

We are seeking an experienced Senior Manager / Manager to lead In-Process Quality Assurance (IPQA) activities across our biologics and cell & gene therapy manufacturing site in Vapi, Gujarat. The role ensures compliance with cGMP, regulatory requirements, Good Documentation Practices (GDP) and ALCOA+ data integrity while supporting batch release and continuous improvement.

Key responsibilities

• Prepare, review, and maintain QA SOPs, templates and IPQA documentation.
• Perform line clearance and verify equipment cleanliness before material issuance.
• Monitor manufacturing operations for adherence to approved procedures, CPPs, CQAs and in‑process controls.
• Review Batch Manufacturing Records, cleaning logs, equipment usage records and ensure completeness.
• Validate in‑process testing results, reconcile manufacturing data and support QA batch disposition.
• Conduct shop‑floor GMP inspections, enforce gowning and documentation standards.
• Identify, investigate and report deviations, non‑conformances and GMP deficiencies.
• Participate in root‑cause analysis, CAPA implementation and effectiveness verification.
• Support media fills, engineering batches, process and cleaning validation, and technology transfer from a QA perspective.
• Maintain inspection‑ready documentation and monitor IPQA quality metrics.

Required profile

• Significant experience in biologics or Cell & Gene Therapy manufacturing.
• Strong knowledge of cGMP, regulatory requirements, GDP and ALCOA+ principles.
• Proven ability to oversee batch release activities and drive continuous quality improvement.
• Experience with deviation investigations, CAPA management and change control.

Required skills

• cGMP compliance
• Good Documentation Practices (GDP)
• ALCOA+ data integrity
• Process validation
• Technology transfer
• Deviation investigation
• CAPA implementation