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 and in full compliance with current GMP requirements

Job Summary

  • This role ensures product batches are manufactured according to approved procedures and in full compliance with current GMP requirements.
  • The incumbent will lead quality oversight of utilities, facilities, and documentation including validation, deviations, and batch records.
  • Candidates must possess a proven track record in site oversight within sterile manufacturing or biologics sectors.

Matching Summary

This role ensures product batches are manufactured according to approved procedures and in full 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 FDA guidance
  • Experience with deviation investigations and CAPAs

Nice-to-have

  • Comfortable working in high-stakes environments
  • Continuous improvement mindset
  • Experience with autologous or allogeneic workflows
  • PMP or Lean Six Sigma certification preferred
  • Collaboration across quality professionals

Key Requirements

  • Bachelor's degree in pharmacy or Life Sciences
  • 5+ years experience in GMP cell therapy or biologics
  • Familiarity with CFDA, EU GMP, and US FDA regulations
  • Willingness to work on-site and support off-hours oversight

Work Rights

Not specified

Tailored Resume

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