Assistant Quality Manager

Role summary

We are seeking an experienced Assistant Quality Manager to independently execute quality control testing and quality assurance activities for GMP-regulated Cell & Gene Therapy (CGT) manufacturing, including CAR-T and Lentiviral vector-based therapeutics. This is an individual contributor role for a technically strong professional who can take ownership of complex testing, investigations, and documentation with minimal supervision, while mentoring junior analysts.

Key Responsibilities

• Oversee GMP-compliant release and in-process QC/QA testing for CAR-T cell therapy products.
• Lead complex assays including viral titer estimation, potency evaluation, co-culture potency, and cytotoxicity testing, ensuring accuracy and timely turnaround.
• Review CAR-T cell assays: appearance checks, viability analysis, residual bead detection, FACS analysis, and immunocytochemistry.
• Verify Bacterial Endotoxin and Mycoplasma testing per compendial and internal methods.
• Prepare, review, and approve Certificates of Analysis (CoA) for clinical and commercial batch release, ensuring compliance with GMP and ALCOA+ standards.
• Take ownership of method qualification, validation, and transfer activities for analytical testing procedures.
• Author, review, and approve SOPs, EOPs, and controlled QC/QA documentation.
• Independently investigate and document deviations and OOS/OOT events; lead root cause analysis and propose CAPA actions for approval.
• Prepare and manage change control documentation for QC/QA methods and processes, assessing quality impact.
• Support audit and regulatory inspection readiness, including compiling documentation and representing QC/QA during audits.
• Ensure data integrity and traceability of all QC/QA records in line with GMP and ALCOA+ principles.
• Collaborate cross-functionally with Manufacturing, Process Development, and Regulatory Affairs to resolve quality issues and support batch disposition timelines.

Required Skills

• Master's or Bachelor's degree in Biomedical Science, Biotechnology, Life Sciences, or related discipline
• Minimum 3-5 years of hands-on QC/QA experience in a GMP-regulated Cell & Gene Therapy, Biologics, or Pharmaceutical manufacturing environment.
• Demonstrated experience independently handling deviations, CAPA, and change control within a QMS.
• Strong working knowledge of GMP, GDP, GLP, ICH-GCP (E6), ICH-Q2(R2), and ISO 13485/ISO 10993 standards.
• Experience supporting or participating in regulatory/customer audits.
• Demonstrated experience with CAR-T/Lentiviral or cell-based product testing preferred.

Location, working & reporting

• Based at our Corporate Office, Thane
• Reports to the Chief Development Officer