Lizz Hansen

About Lizz Hansen

I build disciplined systems that solve complex problems in regulated…

Experience

1. Associate Director, IT Quality & Compliance

   BioCryst Pharmaceuticals, Inc.

   Apr 2024 — Present · 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

• University of Nebraska-Lincoln

  BS

• University of Phoenix

  MSCIS

Skills

• Iso 14971
• Software Documentation
• Root Cause Analysis
• Regulatory Affairs
• Medical Devices
• Capa
• Verification and Validation (V&V)
• Quality Management
• Internal Controls
• Risk Management
• Quality System
• V&V
• Change Management
• Technical Writing
• Gcp
• Biopharmaceuticals
• IT Audit
• Audit
• Process Improvement
• Quality Assurance
• Sarbanes-Oxley Act
• Internal Audit
• Quality Control
• Computer System Validation
• Gmp
• Corrective and Preventive Action (Capa)
• Problem Solving
• U.s. Food and Drug Administration (Fda)
• Documentation
• Iso 13485
• Change Control
• Csv
• 21 Cfr Part 11
• Regulatory Submissions
• Validation
• Gamp
• Software Validation
• Iso
• Business Process Improvement
• Fda