Profile Details : To lead quality operations for CAR-T.This position will act as the central QA authority for CAR-T product approvals across multiple point-of-care centers (POC’s) in India. The role does not involve significant travel but requires strong collaborations with R&D and quality teams of POC’s.

Key Responsibilities

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.

Manage the site Quality Management System (QMS).

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.

Collaborate with cross-functional teams (Manufacturing, QC, Regulatory).
Drive continuous improvement and train staff on GMP and quality culture.

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