Manager, Japan Qa Operations Car T

Bristor Myers Squibb

Otemachi, Japan
50% onsite
Quality oversight of cmos
Cell therapy manufacturing
Batch record review
Provide Quality oversight of routine operations at CMOs in support of cell therapy (CAR-T) product manufacturing

Job Summary

  • Provide Quality oversight of routine operations at CMOs in support of cell therapy (CAR-T) product manufacturing.
  • Responsible for batch record review for disposition and review/approval of CMO deviation investigations, CAPA, and controlled documents.
  • Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment and offers a wide variety of competitive benefits.

Matching Summary

Provide Quality oversight of routine operations at CMOs in support of cell therapy (CAR-T) product manufacturing.

Skills & Requirements

Must-have

  • Quality oversight of CMOs
  • Cell Therapy manufacturing
  • Batch record review
  • Deviation investigation review
  • Regulatory submissions support
  • Japanese and English communication

Nice-to-have

  • Process excellence methods
  • Cross-functional team collaboration
  • Fast-paced environment adaptability
  • Detail-oriented problem solving

Key Requirements

  • More than 5 years' experience in regulated environment
  • Minimum 3 years' experience in quality assurance
  • Master’s or bachelor’s degree in relevant science/engineering field
  • Advanced skills in leading, influencing, and negotiating

Work Rights

Not specified

Tailored Resume

Cover Letter