M&s - Quality Design And Qualification Manager- Ifb- Bj

Sanofi

Beijing, China
**
Cgmp biologics design and qualification
Fda, ema, and chinese pharmacopoeia regulations
Factory acceptance testing (fat), site acceptance testing (sat)
** Sanofi is seeking a Quality Design and Qualification Manager for a new insulin manufacturing facility in Beijing, China. The role involves ensuring compliance with regulatory standards and overseeing the design and qualification processes for the facility, requiring a strong background in biopharma quality management. **

Job Summary

  • The Quality D&Q Manager IFB ensures compliance with FDA, EMA, and Chinese Pharmacopoeia regulations for equipment design and qualification in IFF, Annex 15 and applicable regulations.
  • This role has overall responsibility for participating in project workstreams, ensuring proper execution of design/qualification/validation strategies as well as providing support and guidance for quality processes and procedures.
  • Sanofi offers endless opportunities to grow your talent and drive your career, with a thoughtful rewards package and a wide range of health and wellbeing benefits.

Matching Summary

Match Score: 75

** Sanofi is seeking a Quality Design and Qualification Manager for a new insulin manufacturing facility in Beijing, China. The role involves ensuring compliance with regulatory standards and overseeing the design and qualification processes for the facility, requiring a strong background in biopharma quality management. **

Skills & Requirements

Must-have

  • cGMP biologics Design and Qualification
  • FDA, EMA, and Chinese Pharmacopoeia regulations
  • Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT)
  • DQ, IQ, OQ and PQ
  • complex equipment qualification
  • Project C&Q&V strategy and execution

Nice-to-have

  • Collaborate effectively with peers
  • Act for innovation
  • Develop teams in anticipation of future business needs
  • LEAN oriented, problem solving
  • Open minded and curious to learn new tools

Key Requirements

  • 5-8 years industry experience
  • Biopharma and/or related regulated industry experience
  • Experience working on large capex projects in Asia
  • Degree in Engineering/Science/Pharmacy or equivalent
  • Excellent communication skills in English

Work Rights

Not specified

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