Senior Specialist, Operation, Qa For Manufacturing

AstraZeneca

5+ years gmp cell therapy experience
Bachelor's degree in life sciences
Strong understanding of aseptic processing
This role ensures product batches are manufactured according to approved procedures while maintaining strict compliance with current GMP requirements

Job Summary

  • This role ensures product batches are manufactured according to approved procedures while maintaining strict compliance with current GMP requirements.
  • The incumbent will lead quality oversight activities including validation, deviation investigations, change controls, and batch record approvals for cell therapy products.
  • Candidates must demonstrate the ability to make sound, patient-safety-focused decisions in high-stakes, inspection-ready environments.

Matching Summary

This role ensures product batches are manufactured according to approved procedures while maintaining strict compliance with current GMP requirements.

Skills & Requirements

Must-have

  • 5+ years GMP cell therapy experience
  • Bachelor's degree in Life Sciences
  • Strong understanding of aseptic processing
  • Knowledge of EU GMP Annex 1 and US FDA guidance
  • Experience with batch record review and deviation investigation

Nice-to-have

  • Autologous or allogeneic workflow experience
  • Lean Six Sigma certification preferred
  • Continuous improvement mindset
  • Project management skills
  • Willingness to travel to vendors

Key Requirements

  • Bachelor's degree in pharmacy or Life Sciences
  • 5+ years in GMP cell therapy manufacturing
  • Familiarity with CFDA, EU GMP, and ICH guidelines
  • Experience with MES/eBR and QMS platforms

Work Rights

Not specified

Tailored Resume

Cover Letter