Director Clinical Quality & Development Operations Inspection Excellence

Vertex Pharmaceuticals Incorporated

Base: $184,000 - $276,000; bonus/equity: annual bo...
Hybrid
10 years biopharmaceutical industry experience
3 years supervisor management experience
Advanced gcp cfr ich guidelines knowledge
The Director will lead inspection readiness and preparation activities for Global Clinical Operations, ensuring compliance with health authority regulations

Job Summary

  • The Director will lead inspection readiness and preparation activities for Global Clinical Operations, ensuring compliance with health authority regulations.
  • This role requires managing back-room operations during GCP inspections and developing strategies to remediate findings through CAPA plans.
  • Vertex offers a competitive salary range of $184,000 to $276,000 along with annual bonuses, equity awards, and comprehensive benefits including paid time off.

Matching Summary

The Director will lead inspection readiness and preparation activities for Global Clinical Operations, ensuring compliance with health authority regulations.

Salary

Base: $184,000 - $276,000; Bonus/Equity: Annual bonus and equity awards eligible; Benefits: Medical, dental, vision, PTO, 401(k), educational assistance

Skills & Requirements

Must-have

  • 10 years biopharmaceutical industry experience
  • 3 years supervisor management experience
  • Advanced GCP CFR ICH guidelines knowledge
  • FDA EMA MHRA PMDA CDE inspection expertise
  • Risk-based quality principles application

Nice-to-have

  • Cross-functional leadership skills
  • Continuous process improvement mindset
  • Innovative solution development
  • Stakeholder alignment capabilities
  • Mentorship of junior staff

Key Requirements

  • 10 years biopharmaceutical industry experience
  • 3 years line management experience
  • Advanced understanding of GCP and regulatory guidelines

Work Rights

Not specified

Tailored Resume

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