Associate Director, Quality Assurance

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 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).

This role 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 and leads quality activities for product launches including GMP inspection readiness and coordination.

This position includes the role of Quality Assurance Supervisor which is required by the Pharmaceutical and Medical Device (PMD) Act to be appointed to the Marketing Authorization Holder (MAH) under the supervision of Chief Pharmaceutical Officer (CPO).

Principal Accountabilities

Compliance in Japan & GQP activities

• Oversees quality related activities and operations to assure all products are compliant with Japanese regulations and Biogen procedures.
• Systematically and consistently reviews quality activities to improve efficiencies and enhance compliance.
• Oversees quality operations as described in Japanese regulations and Biogen procedures such as batch release deviation handling change control self-inspection quality agreement management trainings technical product complaint handling and document management.
• Maintains and improves Japanese Quality Management System in alignment Biogen procedures and global standards.
• Oversees management of customer Complaints assuring alignment with Commercial and Marketing team.
• Improves product quality through analysis of Complaints and Quality Information.
• Participate to Sanyaku-kai and maintain required communication with authorities including Management of GMP submission for Biogen Product licensed in Japan and Foreign Manufacturer Accreditation (FMA)
• Inspection Management for Biogen Japan licenses
• Develops Quality Strategy to meet Global and Local objectives

Assurance Supervisor (as required by PMD Act Revised May 2025)

• Acts as the designated representative of the MAH in matters related to Quality Assurance in accordance with Japanese regulatory requirements.
• Holds independent and single-point accountability for ensuring the QA/QC teams operate in full compliance with PMD Act and other applicable Japanese regulations.
• Is legally required to provide updates on quality compliance and GQP activities to the CPO and must submit formal written opinions when necessary.
• May receive instructions or oversight directly from the Minister of MHLW who holds authority to request changes to MAH operations concerning quality assurance.
• Oversees the quality control system for drugs ensuring all related documentation is properly maintained and submitted to MHLW in accordance with Japanese law.
• This accountability is distinct and separate from senior leadership groupings such as Sanyaku-kai; the roles regulatory responsibilities exist independently of corporate hierarchy.
• Ensures the alignment of internal quality systems with national regulatory requirements and serves as a key point of contact during audits inspections and interactions with Japanese health authorities (e.g. PMDA MHLW Tokyo Metropolitan Government)

Party Management (CMO/CLO) in Japan

• Ensures CMO and CLO perform manufacturing and quality control as per Biogen standards
• Assures strategic alliances with CMO and CLO to ensure the high-quality products are released on time.
• Revise and/or update quality agreement with CMO CLO and 3PL (Third Party Logistics) on time to comply with Japanese regulation and Biogen PRCD.
• Assess CMO/CLO from QA/QC perspective to obtain the best quality and operations in the cost effectively manner when the change of the supplier is required.

4.Alliance between Japanese and Global functions

• Ensure Biogen procedures are in place by constantly liaising with Global QA/QC.
• Drives Global thinking while acting locally
• Ensure the products are in line with Japanese quality requirement working closely with Quality and External Manufacturing Team.
• Work closely with relevant functions in Japan to deploy QMS (Quality Management System) and provide key information as a QA/QC representative.

Minimum Education Requirements

• University bachelors degree in supply chain Pharmacy or Science field preferred
• Good level of English Language proficiency for daily business needs with Global stakeholders

Minimum Experience Requirements

• 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