Associate Director Clinical Program Quality

Takeda

Massachusetts, United States
Base: $137,000.00 - $215,270.00; bonus/equity: eli...
Fully remote
10 years pharmaceutical industry experience
7 years gcp quality assurance experience
Ich gcp and global regulatory knowledge
Takeda is seeking an Associate Director of Clinical Program Quality in Massachusetts to oversee quality assurance for global clinical research programs. The role emphasizes patient safety, compliance, and collaboration with stakeholders to ensure the successful delivery of complex clinical programs

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 competitive salary range of $137,000 to $215,270 along with comprehensive benefits including medical insurance, 401(k) matching, and up to 120 hours of paid vacation.

Matching Summary

Match Score: 85

Takeda is seeking an Associate Director of Clinical Program Quality in Massachusetts to oversee quality assurance for global clinical research programs. The role emphasizes patient safety, compliance, and collaboration with stakeholders to ensure the successful delivery of complex clinical programs.

Salary

Base: $137,000.00 - $215,270.00; Bonus/Equity: Eligible for short-term and/or long-term incentives; Benefits: Medical, dental, vision, 401(k), disability, life insurance, tuition reimbursement, 80 hours sick time, 120 hours vacation

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 planning
  • Health authority inspection management

Nice-to-have

  • Stakeholder management in matrix environment
  • Mentoring and cross-functional collaboration
  • Root cause analysis and CAPA development
  • Complex issue resolution skills
  • Innovation-driven patient safety focus

Key Requirements

  • Bachelor's degree required
  • Minimum 10 years in pharma/biotech
  • Minimum 7 years GCP QA experience
  • Advanced expertise in audit planning and reporting

Work Rights

Not specified

Tailored Resume

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