Senior Quality Specialist

Sanofi

Japan
Japanese gmp/gqp, gdp, glp knowledge
Regulatory inspection management
Quality assurance in pharmaceutical r&d
As Senior Quality Specialist, you will lead all quality-related activities for Vaccine R&D in Japan, ensuring compliance with local and global standards while supporting timely product launches

Job Summary

  • As Senior Quality Specialist, you will lead all quality-related activities for Vaccine R&D in Japan, ensuring compliance with local and global standards while supporting timely product launches.
  • You will play a critical role in inspection readiness, regulatory compliance, and quality oversight of clinical contract manufacturers to help protect half a billion lives every year.
  • Sanofi offers career development opportunities including mentoring, international mobility, and a diverse, inclusive workplace dedicated to advancing innovative vaccine science.

Matching Summary

As Senior Quality Specialist, you will lead all quality-related activities for Vaccine R&D in Japan, ensuring compliance with local and global standards while supporting timely product launches.

Skills & Requirements

Must-have

  • Japanese GMP/GQP, GDP, GLP knowledge
  • Regulatory inspection management
  • Quality assurance in pharmaceutical R&D
  • Audit and third-party oversight
  • Cross-functional team collaboration
  • Inspection readiness and product launch

Nice-to-have

  • AI-driven research environment
  • Global and local stakeholder engagement
  • Training and guidance delivery
  • Networking and negotiation skills
  • Agility in regulatory response

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter