Senior Quality Specialist

Sanofi Genzyme

Tokyo, Japan
Japanese gmp/gqp/gdp/glp knowledge
Regulatory inspection readiness management
Third-party audit and oversight experience
Lead all quality-related activities for Vaccine R&D in Japan ensuring compliance with local and global standards

Job Summary

  • Lead all quality-related activities for Vaccine R&D in Japan ensuring compliance with local and global standards.
  • Act as the local Quality Leader responsible for inspection readiness and coordinating cross-functional teams for new product launches.
  • Provide quality oversight for clinical contract manufacturers and manage audits of local manufacturing and distribution operations.

Matching Summary

Lead all quality-related activities for Vaccine R&D in Japan ensuring compliance with local and global standards.

Skills & Requirements

Must-have

  • Japanese GMP/GQP/GDP/GLP knowledge
  • Regulatory inspection readiness management
  • Third-party audit and oversight experience
  • Investigational product release authority
  • CTD submission dossier quality review

Nice-to-have

  • Product launch readiness in Japan
  • Cross-functional global team collaboration
  • AI-driven research environment exposure
  • Strong networking and negotiation skills

Key Requirements

  • Bachelor's degree in Pharmacy, Chemistry, or Biology
  • Extensive pharmaceutical quality assurance experience
  • Proven track record managing regulatory inspections
  • Native level Japanese and business level English
  • Knowledge of PMDA and MHLW regulations

Work Rights

Not specified

Tailored Resume

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