Compliance with japanese pharmaceutical regulations
Management of contract manufacturing organizations
This role is responsible for ensuring all commercial products comply with Good Quality Practice, Good Manufacturing Practice, and Biogen Quality Management System in Japan
Job Summary
This role is responsible for ensuring all commercial products comply with Good Quality Practice, Good Manufacturing Practice, and Biogen Quality Management System in Japan.
The position includes acting as the Quality Assurance Supervisor required by the Pharmaceutical and Medical Device Act, providing leadership and regulatory compliance oversight.
Biogen offers a collaborative environment with opportunities for learning, growth, and making a significant impact in delivering life-changing medicines.
Matching Summary
This role is responsible for ensuring all commercial products comply with Good Quality Practice, Good Manufacturing Practice, and Biogen Quality Management System in Japan.
Skills & Requirements
Must-have
Quality Assurance and Control operations
Compliance with Japanese pharmaceutical regulations
Management of Contract Manufacturing Organizations
GMP inspection readiness and coordination
Quality Management System deployment
Leadership of Quality Operations team
Nice-to-have
Cross-functional project management
Strong communication skills
Global and local quality alignment
Strategic alliance management
Experience with regulatory authority interactions
Bilingual English and Japanese communication
Key Requirements
Minimum 10 years GMP or GDP experience
Minimum 3 years manufacturing or regulatory experience