Senior Director, GCP Quality
Vertex Pharmaceuticals · Boston, MA
QualityFull-time$218k–$326kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Vertex Pharmaceuticals seeks a Senior Director of GCP Operational Quality to lead strategic quality risk management and inspection readiness across clinical programs. This role provides oversight of quality strategies, lifecycle risk review, and cross-functional collaboration to ensure clinical quality outcomes and regulatory compliance.
What they're looking for
- Extensive global health regulatory agency knowledge across GCP and pharmacovigilance
- Demonstrated leadership in quality risk management and inspection readiness strategies
- Strong experience engaging clinical, medical, and cross-functional stakeholders
- Expertise in Quality by Design and risk-based quality management approaches
- Track record of developing and implementing quality management systems
- Experience with quality governance, audit oversight, and vendor management
What you'll be doing
- Develop and oversee quality risk management strategies and inspection readiness plans across therapeutic programs
- Design program-specific quality strategies aligned with Global Clinical Operations, Medical Affairs, and Regulatory teams
- Lead implementation of risk-based approaches including Quality by Design and ongoing quality monitoring mechanisms
- Chair integrated GCP QA Operational Management Reviews to assess transparency, inspection readiness, and operational performance
- Partner with QA leadership on tools, metrics, and systems enabling accountability and operational performance management
Privacy & handoff
This role links to Vertex Pharmaceuticals's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.