Associate Director Clinical Program Quality

Takeda

Massachusetts, United States
Base: $137,000.00 - $215,270.00; bonus/equity: sho...
10 years pharmaceutical industry experience
7 years gcp quality assurance experience
Ich gcp and global regulatory knowledge
This role combines global strategic influence with meaningful impact on patient safety, data integrity, and the successful delivery of complex clinical programs across multiple therapeutic areas

Job Summary

  • This role combines global strategic influence with meaningful impact on patient safety, data integrity, and the successful delivery of complex clinical programs across multiple therapeutic areas.
  • The position requires leading pre-approval and health authority inspection readiness while managing investigations into major quality issues and serious GCP breaches.
  • Takeda offers a stimulating career with comprehensive benefits including medical, dental, vision insurance, a 401(k) plan with company match, and up to 80 hours of sick time per year.

Matching Summary

This role combines global strategic influence with meaningful impact on patient safety, data integrity, and the successful delivery of complex clinical programs across multiple therapeutic areas.

Salary

Base: $137,000.00 - $215,270.00; Bonus/Equity: Short-term and/or long-term incentives eligible; Benefits: Medical, dental, vision, 401(k), paid vacation, sick time

Skills & Requirements

Must-have

  • 10 years pharmaceutical industry experience
  • 7 years GCP Quality Assurance experience
  • ICH GCP and global regulatory knowledge
  • Risk-based audit strategy implementation
  • Health authority inspection leadership

Nice-to-have

  • Stakeholder management in matrix environment
  • Mentoring and cross-functional collaboration
  • Root cause analysis expertise
  • Continuous improvement initiatives

Key Requirements

  • Bachelor's degree required
  • At least 10 years in pharma/biotech
  • At least 7 years GCP QA experience
  • Strong judgment and analytical skills

Work Rights

Not specified

Tailored Resume

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