manager - qa

• Serve as the central decision-making point for CAR-T product release across Indian sites(POC’s).
• Develop, implement, and maintain comprehensive QA/QC policies and procedures tailored for CART
• Design and enforce inspection protocols for raw materials, in-process stages, and final products to maintain product integrity.

•  Ensure compliance with GMP, CDSCO, FDA, EMA, and ATMP regulations.
•  Oversee batch release, deviations, CAPAs, change controls, and risk assessments.
•  Prepare for and lead internal/external audits and regulatory inspections.

• Master’s/Bachelor’s in Biotechnology, Life Sciences, Pharmacy, or related field.
• 10-12 years’ experience in pharmaceutical/biologics QA
•  Strong background in GMP, QMS, and regulatory compliance.
•  Experience in cell therapy, biologics preferred.
•  Excellent leadership, communication, and problem-solving skills.

experience