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
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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.
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Facilitate and support the risk management process for assigned projects using the available tools.
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Facilitate identification, investigation and remediation of quality issues as assigned using available tools and methodologies.
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Provide oversight, transparency and tracking of quality issues for assigned studies.
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Assist with preparations, conduct and response/action plan development for
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audits/inspections as assigned.
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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.
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Partner with project teams to achieve and maintain inspection-ready state including story board oversight.
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Develop and cultivate transparent quality relationships, while managing
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expectations with client quality representatives, including when needed
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fulfilling the role of Portfolio Quality Lead.
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Identify areas for continuous improvement of the Quality Management System by submitting feedback on processes, participating in process improvement initiatives as requested.
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Maintain compliance with Parexel standards.
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Mentor new PQRLs or EP Quality Specialist as needed
Education
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Bachelor’s Degree in Life Sciences
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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.