Manager Or Staff, Quality Systems & Compliance, Osaka Site / 大阪工場 品質システム・コンプライアンス担当（課長代理/一般社員）

Takeda

Osaka, Japan
Base: not specified; bonus: twice a year; benefits...
Native japanese proficiency required
Gmp regulatory knowledge and experience
Leadership of quality assurance teams
This role leads Quality Systems & Compliance activities to ensure global product quality and regulatory adherence for sterile injectables

Job Summary

  • This role leads Quality Systems & Compliance activities to ensure global product quality and regulatory adherence for sterile injectables.
  • The position requires managing document structures, training programs, and inspection readiness while driving a culture of data integrity.
  • Takeda offers competitive compensation including annual salary increases, twice-yearly bonuses, and comprehensive benefits like stock ownership.

Matching Summary

This role leads Quality Systems & Compliance activities to ensure global product quality and regulatory adherence for sterile injectables.

Salary

Base: Not specified; Bonus: Twice a year; Benefits: Commutation, Housing, Overtime, Social Insurance, Pension, Stock Ownership

Skills & Requirements

Must-have

  • Native Japanese proficiency required
  • GMP regulatory knowledge and experience
  • Leadership of quality assurance teams
  • Experience with international regulatory inspections
  • Change control and validation management

Nice-to-have

  • Business level English communication skills
  • Experience with sterile injectable products
  • TrackWise Deviation/CAPA software expertise
  • SAP system familiarity
  • Agile continuous improvement methodologies

Key Requirements

  • Bachelor's degree in Chemistry, Pharmacy, Engineering, or Biology
  • Licensed Pharmacist qualification (preferred)
  • Proven leadership experience in GMP environments
  • Experience handling domestic and international regulatory audits

Work Rights

Not specified

Tailored Resume

Cover Letter