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Lizz Hansen

Associate Director, IT Quality & Compliance @BioCryst Pharmaceuticals, Inc.

Denver, CO, US
EMAILS
l••••••@biocryst.com
MOBILE NUMBERS
+19•••••••10

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WORK HISTORY

Apr 2024 — Present

Associate Director, IT Quality & Compliance @BioCryst Pharmaceuticals, Inc.

Raleigh, NC, US

Lead enterprise IT Quality & Compliance governance across GxP and SOX environments.• Directed CSV → CSA transition, reducing validation timelines by 67%• Delivered business continuity refresh across 65 critical systems in under 9 months• Streamlined audit readiness: automated dashboards fulfill 25% of requests proactively• Cut training backlog by 95%, sustaining zero overdue records• Coach system owners on right-sized, automated, sustainable controls

EDUCATION

N/A

University of Nebraska-Lincoln

BS

N/A

University of Phoenix

MSCIS

SKILLS

Iso 14971Software DocumentationRoot Cause AnalysisRegulatory AffairsMedical DevicesCapaVerification and Validation (V&V)Quality ManagementInternal ControlsRisk ManagementQuality SystemV&VChange ManagementTechnical WritingGcpBiopharmaceuticalsIT AuditAuditProcess ImprovementQuality AssuranceSarbanes-Oxley ActInternal AuditQuality ControlComputer System ValidationGmpCorrective and Preventive Action (Capa)Problem SolvingU.s. Food and Drug Administration (Fda)DocumentationIso 13485Change ControlCsv21 Cfr Part 11Regulatory SubmissionsValidationGampSoftware ValidationIsoBusiness Process ImprovementFda

ABOUT LIZZ HANSEN

I build disciplined systems that solve complex problems in regulated…

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