Senior Quality Specialist
Core
Lead quality-related activities for Vaccine R&D in Japan, ensuring compliance with local and global standards while supporting timely product launches.
Role type
Senior Quality Specialist (Expert Japan)
Builds
Vaccine R&D operations in Japan
Domain
Biopharma / Vaccines / Regulatory Compliance
Deliverable
client delivery
Required skills
Japanese GMP/GQP, GDP, GLP knowledge; regulatory inspection management; clinical contract manufacturer oversight; submission dossier review; corrective and preventive action planning; quality management system maintenance
Preferred skills
Product launch experience in Japan; cross-functional collaboration; training and guidance delivery
Technologies
None stated
Responsibilities
Act as local Quality Leader for inspection readiness and product launch readiness; Review submission dossiers for compliance with Japanese regulatory requirements; Plan and conduct audits of local manufacturing, distribution, and laboratory operations; Oversee the release of investigational medicinal products; Maintain and continuously improve quality management systems
Seniority
Senior, hands-on IC
