Head Of Japan Qaqc& Statutory Quality Supervisor

Biogen

Tokyo, Japan
Quality assurance
Quality control
Gmp compliance
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

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.
  • Acts as the designated representative of the MAH in matters related to Quality Assurance in accordance with Japanese regulatory requirements.
  • We are a global team with a commitment to excellence, and a pioneering spirit.

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 namely Good Quality Practice, Good Manufacturing Practice and Biogen Quality Management System.

Skills & Requirements

Must-have

  • Quality Assurance
  • Quality Control
  • GMP compliance
  • GQP activities
  • Product release
  • Third-party quality oversight

Nice-to-have

  • Pioneering spirit
  • Inclusion and belonging
  • Life-changing medicines
  • Global thinking, local action

Key Requirements

  • Min. 10 years GMP/GDP experience
  • Min 3 years manufacturing, development, quality, or regulatory experience
  • Proven ability for MHLW Ordinance duties
  • University bachelor’s degree
  • Good English proficiency
  • People management experience
  • Project management experience

Work Rights

Not specified

Tailored Resume

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