Project Quality Lead II

Home Based, US

As a Project Quality & Risk Lead II you will 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.

Accountabilities

• Analyze key risk indicators and investigate risk signals by performing, reporting and coordinating Risk Signal Evaluations (RSE) for assigned projects using dashboards, reports, metrics and other available tools.
• Facilitate and support 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 experts.
• Partner with project teams to achieve and maintain inspection-ready state including story board oversight.
• Develop and cultivate transparent quality relationships, while managing
• expectations with client quality representatives, including when needed
• fulfilling the role of Portfolio 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 or EP Quality Specialist as needed

Education

• Bachelor’s Degree in Life Sciences