Senior Project Quality Risk Lead

Parexel International Corporation

Glendale, California

Office Based, Glendale, CA

As a Sr Project Quality & Risk Lead you will partner with operational delivery teams (Project Leads, Clinical Operational Leads & Site Management) focused on first-time quality, robust risk and issue management and maintain an inspection-ready state. You will serve as the SME (subject matter expert) and offer quality expertise through the execution of quality SOPs to support operations, leadership and clients. QualificationsSkillsAnalyze 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 toolsFacilitate and drive the risk management process using the available toolsFacilitate identification, investigation and remediation of quality issues using available tools and methodologies.Provide oversight, transparency and tracking of quality issues Assist with preparations, conduct and response/action plan development for audits/inspectionsProvide 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 expertsPartner with project teams to achieve and maintain inspection-ready state including story board oversight.Knowledge & Experience5+ years’ experience in early phase or late phase clinical researchExperience using root cause methodologies (5-whys, fishbone diagram, etc.)Knowledge of ICH-GCP principlesEnglish proficiency (written and oral)EducationEducated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experienceEEO DisclaimerParexel 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.

2022-07-29 00:05:28

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