Sr. Project Quality & Risk Lead
Parexel International Corporation
USA - Any Region - Home Based
Home Based, US
As a Sr Project Quality & risk Lead with Parexel 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 through the execution of first time quality through 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 for assigned projects using the available toolsFacilitate identification, investigation and remediation of quality issues as assigned using available tools and methodologies. Provide oversight, transparency and tracking of quality issues for assigned studiesAssist with preparations, conduct and response/action plan development for audits/inspections as assignedProvide 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 oversightDevelop and cultivate transparent quality relationships, while managing expectations with client quality representatives, including when needed fulfilling the roles of Portfolio/Client Quality LeadIdentify areas for continuous improvement of the Quality Management System by submitting feedback on processes, participating in process improvement initiatives as requestedAct as an integration partner to new or junior level staff.EducationBachelors degree, Life Sciences, Business Management or relevant degree
EEO 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.