Cell & Gene Therapy QA - Manager (Lead)

2 weeks ago


Bengaluru, Karnataka, India Aurigene Oncology Limited Full time

  • Establish and maintain the quality system standards per Schedule M for Cell and Gene Therapy R&D and GMP manufacturing sites.
  • Ensure Quality Oversight to ensure consistency of standards, harmonization, sharing of best practice and productivity.
  • Operational lead of CAR-T / CAR-NK QA unit staff.
  • Ensure qualified personnel are available in QA operations for CAR-T / CAR-NK program.
  • Drive continuous improvement of the quality system to meet and sustain compliance with internal and external regulatory requirements.
  • Conduct Quality Reviews to evaluate if processes and deliverables fulfil the requirements for quality, to uncover errors or deficiencies in processes and deliverables, and to identify strengths and opportunities for improvement.
  • Support the development and delivery of training in quality matters.
  • Interface with other line functions involved in CAR-T to ensure Quality operations and practices are aligned with regulatory expectations in India and industry best practices.
  • Prepare and follow internal authority inspections.
  • Oversee deviations, investigations and audits.
  • Interact heavily with manufacturing and QC teams, making sure products are getting released on time and within compliance.
  • Involved in regulatory and customer audits.
  • Being able to work within a group, and work within a very collaborative type culture.


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