Colombia, Remote **Job ID** R0000012875 **Category** Quality Management **ABOUT THIS ROLE**: **México, Colombia or Brazil - home based - Project Quality & Risk Lead** **Job Purpose**: Partner with operational delivery teams focusing on first-time quality, robust risk, and issue management, and maintaining an inspection-ready state. Provide quality expertise through the execution of quality SOPs to support operations, leadership, and clients. **What you'll do**: - Analyze key risk indicators and investigate risk signals by performing, reporting, and coordinating risk-based quality evaluations for assigned projects using dashboards, reports, metrics, and other available tools. - Facilitate and drive the risk management process for assigned projects using the available tools. - Facilitate identification, investigation, and remediation of quality issues as assigned using available tools and methodologies. Provide oversight, transparency, and tracking of quality issues for assigned studies. - Assist with preparations, conduct, and response/action plan development for audits/inspections as assigned. - Partner with project teams to achieve and maintain inspection-ready state including storyboard oversight. - Develop and cultivate transparent quality relationships, while managing expectations with client quality representatives, including when needed fulfilling the roles of Portfolio/Client Quality Lead. - Identify areas for continuous improvement of the Quality Management System by submitting feedback on processes, participating in process improvement initiatives as requested. - Maintain compliance with Parexel standards. - Mentor new PQRLs as assigned. **Requirements**: - Bachelor’s Degree in science or other health-related discipline preferred. - ** Clinical Trials experience as CRA is mandatory**: - English proficiency (written and oral) LI-REMOTE