Quality assurance for clinical contract manufacturers
As Senior Quality Specialist within the Vaccine R&D Quality Operations team, you will lead all quality-related activities for Vaccine R&D in Japan, ensuring compliance with local and global quality standards while supporting timely product launches
Job Summary
As Senior Quality Specialist within the Vaccine R&D Quality Operations team, you will lead all quality-related activities for Vaccine R&D in Japan, ensuring compliance with local and global quality standards while supporting timely product launches.
You will play a critical role in ensuring product launch readiness and regulatory compliance for life-saving vaccines in Japan, contributing to one of the largest global vaccination efforts in healthcare.
Sanofi offers career development opportunities with mentoring, international mobility programs, and a diverse, inclusive workplace dedicated to protecting millions worldwide.
Matching Summary
As Senior Quality Specialist within the Vaccine R&D Quality Operations team, you will lead all quality-related activities for Vaccine R&D in Japan, ensuring compliance with local and global quality standards while supporting timely product launches.
Skills & Requirements
Must-have
Japanese GMP/GQP, GDP, GLP compliance
Regulatory inspection management
Quality assurance for clinical contract manufacturers
Audit planning and execution
Cross-functional team collaboration
Inspection readiness and product launch readiness
Nice-to-have
Strong networking and negotiation skills
Leadership in cross-functional collaboration
Experience with mRNA vaccine platforms
Agility in responding to regulatory changes
Training and guidance provision
Key Requirements
Bachelor's degree in Pharmacy, Chemistry, Biology or related field