Senior Quality Specialist

Sanofi UK

Tokyo, Japan
On-site
Inspection readiness and regulatory compliance
Third party management and auditing
Investigational product management
Sanofi UK is seeking a Senior Quality Specialist based in Tokyo, Japan, to oversee quality-related activities for Vaccine R&D, ensuring compliance with local and global standards. The role requires a strong background in pharmaceutical quality assurance, particularly in regulatory inspections and audits, while offering the opportunity to contribute to significant global vaccination efforts

Job Summary

  • Lead all quality-related activities for Vaccine R&D in Japan, ensuring compliance with local and global quality standards while supporting timely product launches.
  • Plan and conduct audits of local manufacturing, distribution, and laboratory operations to ensure compliance with applicable standards.
  • Maintain and continuously improve quality management systems in alignment with global and local standards, ensuring robust documentation and data integrity.

Matching Summary

Match Score: 85

Sanofi UK is seeking a Senior Quality Specialist based in Tokyo, Japan, to oversee quality-related activities for Vaccine R&D, ensuring compliance with local and global standards. The role requires a strong background in pharmaceutical quality assurance, particularly in regulatory inspections and audits, while offering the opportunity to contribute to significant global vaccination efforts.

Skills & Requirements

Must-have

  • Inspection readiness and regulatory compliance
  • Third party management and auditing
  • Investigational product management
  • Quality systems and stakeholder collaboration
  • Japanese GMP/GQP, GDP, GLP compliance

Nice-to-have

  • AI-driven breakthroughs
  • mRNA innovation
  • Cross-functional team collaboration
  • Continuous improvement initiatives

Key Requirements

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

Work Rights

Not specified

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