R&d Quality Laboratory Oversight (associate Director)

Takeda

Kanagawa, Japan
Not specified; bonus pyyment: twice a year; benefi...
Gmp/glp laboratory quality oversight
Alcoa+ data integrity management
Analytical method development and validation
This role serves as a key quality leader ensuring high-quality, compliant analytical testing across Takeda's global network of R&D laboratories

Job Summary

  • This role serves as a key quality leader ensuring high-quality, compliant analytical testing across Takeda's global network of R&D laboratories.
  • The position requires overseeing the entire analytical lifecycle including method development, validation, release testing, and stability testing to support regulatory submissions.
  • Candidates will partner closely with Pharmaceutical Sciences, Regulatory, Manufacturing, and QA teams to drive timely CAPAs and protect patient safety.

Matching Summary

This role serves as a key quality leader ensuring high-quality, compliant analytical testing across Takeda's global network of R&D laboratories.

Salary

Not specified; Bonus Payment: Twice a year; Benefits: Social Insurance, Retirement Pension, Employee Stock Ownership Program

Skills & Requirements

Must-have

  • GMP/GLP laboratory quality oversight
  • ALCOA+ data integrity management
  • Analytical method development and validation
  • Regulatory submission support IND CTA NDA BLA
  • Deviation and CAPA investigation leadership

Nice-to-have

  • Experience with multiple drug modalities
  • Global matrix environment collaboration skills
  • Strong cross-functional partnership abilities

Key Requirements

  • Bachelor's degree in Life Sciences or related field
  • 7+ years experience in GxP laboratory quality oversight
  • MS/PhD preferred in relevant scientific discipline

Work Rights

Not specified

Tailored Resume

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