Quality Assurance Associate

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 manufacturing.
• Design and enforce inspection protocols for raw materials, in-process stages, and final products to maintain product integrity.
• Lead the QA function and 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.

Qualifications:

• Master’s/Bachelor’s in Biotechnology, Life Sciences, Pharmacy, or related field.
• 12–15 years’ experience in pharmaceutical/biologics QA, with 5+ years in leadership.
• Strong background in GMP, QMS, and regulatory compliance.
• Experience in cell therapy, biologics, or aseptic manufacturing preferred.
• Excellent leadership, communication, and problem-solving skills.