RBQM Lead: Risk-Based Quality Management

Summit-Therapeutics; Princeton (NJ); On-site; USD 174,000 - 204,000; Full time

Job summary

Summit Therapeutics Inc. is seeking an Associate Director, Risk Based Quality Management Lead to drive RBQM across clinical studies, partnering with operations, data management, medical monitoring and CROs.

You will implement and maintain risk management, centralized monitoring, KRIs, QTLs, and targeted monitoring strategies to protect participant safety and data integrity. The role requires 10+ years in clinical operations with RBQM expertise, global trial experience, and strong analytical,

Qualifications

• 10+ years of clinical operations experience in sponsor pharmaceutical or biotechnology organizations.
• 7+ years of direct RBQM, centralized monitoring, risk-based monitoring, or study management experience.
• Experience supporting global Phase II and/or Phase III clinical trials.
• Ability to interpret complex scientific, clinical, and operational data to identify quality and compliance risks.

Responsibilities

• Lead RBQM planning, execution, and ongoing risk oversight across studies.
• Develop and maintain study-specific RBQM Plans and CtQ factors.
• Facilitate cross-functional risk workshops and maintain risk tools.
• Document, score, track, and reassess risks and mitigation actions.
• Coordinate CAPA, inspection readiness, and risk review meetings.

Education

Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical-related areas

Tools

RBQM technology

Clinical analytics platforms

Job description

Summit Therapeutics Inc. is seeking an Associate Director, Risk Based Quality Management Lead to drive RBQM across clinical studies, partnering with operations, data management, medical monitoring and CROs.

You will implement and maintain risk management, centralized monitoring, KRIs, QTLs, and targeted monitoring strategies to protect participant safety and data integrity. The role requires 10+ years in clinical operations with RBQM expertise, global trial experience, and strong analytical,