Manager, Risk-Based Quality Management (RBQM)

The Role: The Manager, Risk-Based Quality Management (RBQM) supports the execution and continuous improvement of risk-based approaches in clinical trial quality management. This role works cross-functionally to help ensure patient safety, data integrity, and compliance through effective implementation of RBQM principles, including risk management, central monitoring, and monitoring oversight. The Manager partners closely with study teams, CROs, and Quality functions to ensure RBQM activities are conducted according to defined processes, timelines, and regulatory expectations. Here’s What You’ll Be Doing: Risk Management Support Support study- and program-level risk assessments, including identification of Critical to Quality (CTQ) factors, development of Quality Tolerance Limits (QTLs) and Key Risk Indicators (KRIs), and tracking of mitigation actions. Assist in developing and maintaining the Integrated Quality Risk Management Plan (IQRMP). Contribute to CSR sections related to Risk Management and QTLs, ensuring traceability and documentation accuracy. Maintain documentation for QTL definitions, parameters, and thresholds. Central Monitoring Execution Participate in setup and review of centralized monitoring activities, including configuration and validation of KRIs, QTLs, and related reports in monit