Associate Director, Clinical Quality Assurance (cqa), Tdc-j

Takeda

Osaka, Japan
Gcp audit and compliance oversight
Risk-based audits
Regulatory inspections
Provides leadership and guidance to the CQA Program Managers and partner with key stakeholders that are integral to clinical development activities, as applicable

Job Summary

  • Provides leadership and guidance to the CQA Program Managers and partner with key stakeholders that are integral to clinical development activities, as applicable.
  • Oversees and provides necessary support for the GCP components of egulatory Inspections.
  • Takeda offers a comprehensive compensation and benefits package including allowances, annual salary increases, twice-yearly bonus payments, and a wide range of holidays and paid leaves.

Matching Summary

Provides leadership and guidance to the CQA Program Managers and partner with key stakeholders that are integral to clinical development activities, as applicable.

Skills & Requirements

Must-have

  • GCP audit and compliance oversight
  • risk-based audits
  • regulatory inspections
  • ICH GCP and global regulations
  • clinical development activities

Nice-to-have

  • leadership and guidance
  • strategic audit plan
  • negotiates and influences
  • creative solutions to complex problems
  • people management

Key Requirements

  • Minimum of 10 years of experience
  • Minimum 7 years of GCP-related Quality Assurance
  • Minimum 5 years leading teams
  • BA/BS degree required
  • Japanese (native level)
  • English (business level)

Work Rights

Not specified

Tailored Resume

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