Hybrid Head of Japan QAQC, Statutory Quality Supervisor

at Biogen

• Job title: Head of Japan QAQC, Statutory Quality Supervisor
• Job type: Full Time
• Experience level: Lead
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Tokyo, Japan

About the role

• Leading QA and QC operations ensuring compliance in Biogen Japan. Overseeing quality assurance initiatives, representing Japan Quality in global forums and managing quality operations.

Responsibilities

• Responsible for Quality Assurance (QA) and Quality Control (QC) operations in Biogen Japan
• Ensure compliance with relevant regulations namely Good Quality Practice, Good Manufacturing Practice and Biogen Quality Management System
• Accountable for assuring release, overseeing quality operations at Contract Manufacturing Organization (CMO), assuring QC testing is performed appropriately through Contract Lab Organization (CLO)
• Drives key PO&T initiatives in Japan, represents Japan Quality in global and affiliate forums
• Provides leadership and direction to the Quality Operations team, builds strong partnerships across stakeholders
• Leads quality activities for product launches, including GMP inspection readiness and coordination
• Oversees quality related activities and operations to assure all products are compliant with Japanese regulations and Biogen procedures
• Maintains and improves Japanese Quality Management System in alignment Biogen procedures and global standards
• Acts as the designated representative of the MAH in matters related to Quality Assurance in accordance with Japanese regulatory requirements
• Oversees the quality control system for drugs, ensuring all related documentation is properly maintained and submitted to MHLW in accordance with Japanese law
• Ensures CMO and CLO perform manufacturing and quality control as per Biogen standards

Requirements

• University bachelor’s degree in supply chain, Pharmacy or Science field preferred
• Good level of English Language proficiency for daily business needs with Global stakeholders
• Min. 10 years of GMP or GDP experience for Medicinal Products Quality and distribution experience
• Proven ability and experience necessary to perform the obligations and the duties specified in the MHLW Ordinance
• Min 3 years’ experience in either manufacturing, development, quality or regulatory.
• Good Knowledge of GLP and technical transfer experience
• People management experience with both direct report and matrix set ups
• Project management experience in broad cross-functional setting
• Extensive and broad communication skills

Benefits

• Competitive salary
• Flexible working hours
• Professional development opportunities
• Global team events