Project Quality & Risk Lead II

Partner with operational delivery teams focusing on first-time quality, robust risk and issue management and maintaining an inspection-ready state. Provide quality expertise to support operations, leadership and clients.

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.

• Provide expert quality advice as assigned, responding to consultancy requests and requests for SOP deviations using ICH-GCP, Parexel processes, regulatory requirements, applicable country requirements, and input of appropriate subject matter [1]experts.

• 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 is required
• English proficiency (written and oral)