Director, Clinical Quality Program Lead (Hybrid)
Vertex Pharmaceuticals
June 27, 2026
Remote friendly (Boston, MA)
United States
Clinical Research and Development
General/Position Summary
The Director, Clinical Quality Program Lead (CQPL) provides quality oversight across a range of study phases within assigned disease area(s) to ensure trials are conducted in accordance with GCP. Oversees real-time inspection readiness, risk management, and quality health.
Key Duties & Responsibilities
- Partner with Global Clinical Operations, Clinical Development, Regulatory, etc. on quality strategies for quality outcomes and inspection readiness.
- Identify quality risks and support implementation of mitigations/contingency plans; provide regular updates to quality leadership and cross-functional stakeholders.
- Oversee and support quality of clinical trials in assigned disease areas with focus on risk management and inspection readiness.
- Lead development, execution, and continuous improvement of quality risk management/mitigation and inspection readiness strategies.
- Provide guidance on risk-based quality approaches (e.g., Quality by Design) and ensure effectiveness of ongoing quality risk monitoring/mitigation.
- Evolve GCQ pillar processes and contribute to departmental goals/objectives; support unified risk/governance oversight.
- Monitor quality and departmental metrics; optimize processes/procedures.
- Lead people management (resource forecasting, hiring, training, goals, performance management, career development; may manage contract staff).
- Consult business partners on proactive, leading quality approaches.
Required Experience
- 10+ years relevant experience, including GCP quality oversight; line management/supervisory experience.
Required Knowledge/Skills
- Expert understanding of ICH-GCP and international regulations (e.g., US Title 21 CFR, EU CTR).
- Demonstrated risk-based quality principles application (e.g., QbD).
- Proven leadership and ability to develop teams.
- Knowledge of industry trends/best practices in regulated quality risk management.
- Strong problem-solving, critical thinking, analytical/data analysis skills.
- Ability to work independently with minimal guidance.
Other Requirements
- Professional clinical trial certification (preferred).
- Travel up to 10%.
Compensation
- Pay range: $188,000 - $282,000.
The Director, Clinical Quality Program Lead (CQPL) provides quality oversight across a range of study phases within assigned disease area(s) to ensure trials are conducted in accordance with GCP. Oversees real-time inspection readiness, risk management, and quality health.
Key Duties & Responsibilities
- Partner with Global Clinical Operations, Clinical Development, Regulatory, etc. on quality strategies for quality outcomes and inspection readiness.
- Identify quality risks and support implementation of mitigations/contingency plans; provide regular updates to quality leadership and cross-functional stakeholders.
- Oversee and support quality of clinical trials in assigned disease areas with focus on risk management and inspection readiness.
- Lead development, execution, and continuous improvement of quality risk management/mitigation and inspection readiness strategies.
- Provide guidance on risk-based quality approaches (e.g., Quality by Design) and ensure effectiveness of ongoing quality risk monitoring/mitigation.
- Evolve GCQ pillar processes and contribute to departmental goals/objectives; support unified risk/governance oversight.
- Monitor quality and departmental metrics; optimize processes/procedures.
- Lead people management (resource forecasting, hiring, training, goals, performance management, career development; may manage contract staff).
- Consult business partners on proactive, leading quality approaches.
Required Experience
- 10+ years relevant experience, including GCP quality oversight; line management/supervisory experience.
Required Knowledge/Skills
- Expert understanding of ICH-GCP and international regulations (e.g., US Title 21 CFR, EU CTR).
- Demonstrated risk-based quality principles application (e.g., QbD).
- Proven leadership and ability to develop teams.
- Knowledge of industry trends/best practices in regulated quality risk management.
- Strong problem-solving, critical thinking, analytical/data analysis skills.
- Ability to work independently with minimal guidance.
Other Requirements
- Professional clinical trial certification (preferred).
- Travel up to 10%.
Compensation
- Pay range: $188,000 - $282,000.