Director, Clinical Quality Program Lead (Hybrid)
Vertex Pharmaceuticals
6 months ago
Remote friendly (Boston, MA)
United States
Clinical Research and Development
Key Duties & Responsibilities
- Partner with business stakeholders across Global Clinical Operations, Clinical Development, Regulatory, etc. for alignment of quality strategies, goals and approaches in support of quality outcomes and real time inspection readiness
- Proactively identify risks to quality and assist with implementation of mitigations/contingency plans; provide regular updates to the R&D Quality Leadership Team and cross-functional stakeholders
- Collaborate cross-functionally to oversee and support the quality of all clinical trials within assigned disease areas, with focus on risk management and inspection readiness
- Oversee development, execution, and continual improvement of quality risk management/mitigation and inspection readiness strategies across assigned disease areas
- Provide leadership and guidance to implementation of risk-based approaches to quality for clinical development programs (e.g., Quality by Design) and ensure effective ongoing quality risk monitoring, mitigation, and management
- Contribute to the strategic evolution of GCQ pillar, including development of key processes and departmental goals/objectives
- Collaborate within RDQ to ensure unified and effective risk & governance oversight models
- Monitor quality and departmental metrics; identify opportunities to optimize processes and procedures
- Responsible for people management (resource forecasting, hiring, training, goal setting, performance management, career development); may manage contract staff
- Engage and consult with business partners to advance proactive and leading quality approaches incorporating best practices
Required Experience
- 10+ years of relevant work experience, including experience in a GCP quality oversight role (or comparable background)
- Line management experience or other supervisory work
Required Knowledge/Skills
- Excellent understanding of ICH-GCP guidelines and international clinical trial regulations (e.g., US Title 21 CFR, EU CTR)
- Demonstrated experience applying risk-based quality principles (e.g., QbD) in a pharmaceutical environment
- Leadership capability for developing individuals and teams within multi-level organizations
- Current knowledge of industry trends and best practices in progressive quality risk management in regulated environments
- Strong problem-solving and critical thinking; analytical/data analysis skills for sound decisions
- Ability to work independently with minimal guidance; organize and prioritize effectively
Other Requirements
- Professional clinical trial certification (e.g., CCRP, RQAP-GCP, etc.) preferred
- Travel required up to 10%
Pay Range
- $188,000 - $282,000
Flex Designation
- Hybrid-Eligible or On-Site Eligible (Hybrid: remote up to two days/week; On-Site: five days/week with ad hoc flexibility)
Disclosure/Role Eligibility (as stated)
- Eligible for an annual bonus and annual equity awards (and potentially overtime where applicable)
- Partner with business stakeholders across Global Clinical Operations, Clinical Development, Regulatory, etc. for alignment of quality strategies, goals and approaches in support of quality outcomes and real time inspection readiness
- Proactively identify risks to quality and assist with implementation of mitigations/contingency plans; provide regular updates to the R&D Quality Leadership Team and cross-functional stakeholders
- Collaborate cross-functionally to oversee and support the quality of all clinical trials within assigned disease areas, with focus on risk management and inspection readiness
- Oversee development, execution, and continual improvement of quality risk management/mitigation and inspection readiness strategies across assigned disease areas
- Provide leadership and guidance to implementation of risk-based approaches to quality for clinical development programs (e.g., Quality by Design) and ensure effective ongoing quality risk monitoring, mitigation, and management
- Contribute to the strategic evolution of GCQ pillar, including development of key processes and departmental goals/objectives
- Collaborate within RDQ to ensure unified and effective risk & governance oversight models
- Monitor quality and departmental metrics; identify opportunities to optimize processes and procedures
- Responsible for people management (resource forecasting, hiring, training, goal setting, performance management, career development); may manage contract staff
- Engage and consult with business partners to advance proactive and leading quality approaches incorporating best practices
Required Experience
- 10+ years of relevant work experience, including experience in a GCP quality oversight role (or comparable background)
- Line management experience or other supervisory work
Required Knowledge/Skills
- Excellent understanding of ICH-GCP guidelines and international clinical trial regulations (e.g., US Title 21 CFR, EU CTR)
- Demonstrated experience applying risk-based quality principles (e.g., QbD) in a pharmaceutical environment
- Leadership capability for developing individuals and teams within multi-level organizations
- Current knowledge of industry trends and best practices in progressive quality risk management in regulated environments
- Strong problem-solving and critical thinking; analytical/data analysis skills for sound decisions
- Ability to work independently with minimal guidance; organize and prioritize effectively
Other Requirements
- Professional clinical trial certification (e.g., CCRP, RQAP-GCP, etc.) preferred
- Travel required up to 10%
Pay Range
- $188,000 - $282,000
Flex Designation
- Hybrid-Eligible or On-Site Eligible (Hybrid: remote up to two days/week; On-Site: five days/week with ad hoc flexibility)
Disclosure/Role Eligibility (as stated)
- Eligible for an annual bonus and annual equity awards (and potentially overtime where applicable)