This role is responsible for ensuring all commercial products comply with Japanese regulations including Good Quality Practice and Good Manufacturing Practice
Job Summary
This role is responsible for ensuring all commercial products comply with Japanese regulations including Good Quality Practice and Good Manufacturing Practice.
The position serves as the legally designated Quality Assurance Supervisor required by the PMD Act, holding independent accountability for quality operations.
Biogen offers a stable environment with opportunities for learning and growth while delivering life-changing medicines to patients.
Matching Summary
This role is responsible for ensuring all commercial products comply with Japanese regulations including Good Quality Practice and Good Manufacturing Practice.
Skills & Requirements
Must-have
Japanese GMP and GQP regulatory compliance
PMD Act Quality Assurance Supervisor role
CMO and CLO third-party management
Batch release and deviation handling
MHLW and PMDA authority interaction
Global quality system alignment
Nice-to-have
Strong cross-functional leadership skills
Experience with product launch activities
Fluency in English for global collaboration
Proven project management capabilities
Strategic alliance building experience
Key Requirements
Minimum 10 years of GMP/GDP experience
Bachelor's degree in Pharmacy or Science
Legal eligibility to serve as MAH QA Supervisor under PMD Act
3+ years in manufacturing, development, quality, or regulatory
Knowledge of GLP and technical transfer
Work Rights
Must have legal right to work in Japan as MAH representative