Responsible for Quality Assurance (QA) and Quality Control (QC) operations in Biogen Japan, to ensure that all commercial products comply with relevant regulations
Job Summary
Responsible for Quality Assurance (QA) and Quality Control (QC) operations in Biogen Japan, to ensure that all commercial products comply with relevant regulations.
Acts as the designated representative of the MAH in matters related to Quality Assurance in accordance with Japanese regulatory requirements.
Ensures CMO and CLO perform manufacturing and quality control as per Biogen standards and assures strategic alliances with CMO and CLO to ensure the high-quality products are released on time.
Matching Summary
Responsible for Quality Assurance (QA) and Quality Control (QC) operations in Biogen Japan, to ensure that all commercial products comply with relevant regulations.
Skills & Requirements
Must-have
Good Quality Practice
Good Manufacturing Practice
Biogen Quality Management System
Pharmaceutical and Medical Device Act
Contract Manufacturing Organization oversight
Contract Lab Organization oversight
Nice-to-have
Pioneering spirit
Commitment to excellence
Inclusion and belonging culture
Life-changing medicines
Key Requirements
Min. 10 years of GMP or GDP experience
Min 3 years’ experience in manufacturing, development, quality or regulatory
Proven ability and experience necessary to perform MHLW Ordinance obligations
University bachelor’s degree in supply chain, Pharmacy or Science field preferred