Project Quality
hace 2 semanas
Additional Locations:
Mexico Destrito, Ciudad de Mexico, Mexico; Remote, São Paulo, Brazil
Job ID R
Category Quality Management
ABOUT THIS ROLE:
Argentina, México, Colombia or Brazil - home based - Project Quality & Risk Lead
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 riskbased 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.
- Partner with project teams to achieve and maintain inspectionready 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 healthrelated discipline preferred.
Clinical Trials experience:
-
English proficiency (written and oral) Mandatory:
- Experience in Quality Assurance or Data Operations related to clinical trials
- Functional lead experience
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