Head Of Japan Qaqc& Statutory Quality Supervisor

Biogen Inc

Tokyo, Japan
10+ years gmp/gdp experience
Japanese pmd act regulatory compliance
Qa supervisor role under mah requirements
This role is responsible for ensuring all commercial products in Biogen Japan comply with Japanese regulations including Good Quality Practice and Good Manufacturing Practice

Job Summary

  • This role is responsible for ensuring all commercial products in Biogen Japan 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 QA/QC operations and reporting to the Chief Pharmaceutical Officer.
  • Biogen fosters a culture of inclusion and belonging where diverse perspectives drive innovation while delivering life-changing medicines to patients globally.

Matching Summary

This role is responsible for ensuring all commercial products in Biogen Japan comply with Japanese regulations including Good Quality Practice and Good Manufacturing Practice.

Skills & Requirements

Must-have

  • 10+ years GMP/GDP experience
  • Japanese PMD Act regulatory compliance
  • QA Supervisor role under MAH requirements
  • CMO and CLO third-party management
  • GQP system implementation and oversight

Nice-to-have

  • Global quality strategy alignment
  • Cross-functional project leadership
  • Strong stakeholder partnership building
  • Product launch quality coordination
  • English proficiency for global teams

Key Requirements

  • Minimum 10 years GMP or GDP experience
  • Bachelor's degree in Pharmacy, Supply Chain, or Science
  • Proven ability to perform obligations per MHLW Ordinance
  • 3+ years experience in manufacturing, development, quality, or regulatory
  • Legal eligibility to serve as MAH Quality Representative in Japan

Work Rights

Must have legal eligibility to serve as MAH Quality Representative under Japanese law

Tailored Resume

Cover Letter