Associate Director, Risk Based Quality Management Lead
$174,000–$204,000 year
On-sitePrinceton, New Jersey, United States
Job Summary
Lead operational execution of Risk-Based Quality Management (RBQM) activities from protocol development through study closeout. Develop and maintain study-specific RBQM Plans, Critical-to-Quality factors, and Risk Assessment and Categorization Tools (RACTs). Establish and monitor Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs), investigating threshold breaches and coordinating corrective actions. Implement centralized monitoring strategies to ensure data accuracy, completeness, and consistency across sites, utilizing real-time surveillance to identify outliers and unusual patterns. Facilitate cross-functional risk review meetings, prepare dashboards, and present significant risk signals to study teams. Support investigations of quality events, define corrective and preventive actions (CAPAs), and maintain inspection-ready documentation for regulatory audits. Ensure all RBQM activities comply with GCP, ICH guidelines, and FDA regulations.
Required Qualifications
- 10+ years of clinical operations experience in sponsor pharmaceutical or biotechnology organizations
- 7+ years of direct RBQM, centralized monitoring, risk-based monitoring, clinical quality, or study management experience
- Experience supporting global Phase II and/or Phase III clinical trials
- Experience conducting risk assessments; developing and managing KRIs and QTLs; and facilitating risk review meetings
- Demonstrated ability to interpret complex scientific, clinical, and operational data to identify quality and compliance risks and support centralized trial monitoring
- Experience working with CROs, RBQM technology and clinical analytics platforms
- Proven ability to oversee large, complex studies managed in-house and through CRO partners
- Demonstrated sound judgment and problem-solving ability related to regulatory requirements, external partners, timelines, and complex clinical programs
- Excellent planning, communication, negotiation, and organizational skills
- Strong knowledge of the drug development process, ICH guidelines, and GCP, with a deep understanding of clinical trial execution and the ability to apply this knowledge to complex global studies
Desired Qualifications
- Bachelor's degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical-related areas preferred
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