Alexandria Curlow
Director, Quality Assurance @Tempus AI
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WORK HISTORY
Director, Quality Assurance @Tempus AI
Oversees the risk-based Quality Management System (QMS) for the oncology CRO division.• Collaborates with Executive Management to establish quality goals and ensure regulatory compliance.• Manages the audit program, including internal, investigator site, trial master file (TMF), and vendor / supplier audits.• Manages controlled document management program, including authoring, reviewing, and approving documents to instill quality by design principles and a risk based, fit for purpose approach.• Manages quality events, including non-conformance/deviation and CAPA processes.• Tracks and reports on KQIs / KPIs during routine quality management reviews to drive continuous improvement.• Acts as the Clinical Quality SME to support clinical study teams and represent quality during client interactions.
EDUCATION
Baruch College
Bachelor of Science - BS, Biology, General
Pace University
Master’s Degree, Physician Assistant
ABOUT ALEXANDRIA CURLOW
Clinical Quality leader with 12+ years of GCP experience driving inspection and audit readiness, risk management, GCP compliance, and process improvement across decentralized, hybrid, and traditional clinical studies. Proven track record of building quality systems, implementing digital solutions, leading cross-functional teams, and ensuring regulatory compliance in highly dynamic environments. Holds ASQ Certified Quality Auditor (CQA) and has experience as a licensed Physician Assistant.
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