Margaret Hindley
MBA, PhD, CQA, CQE, Director, Computer Software Assurance, IT
- Taiho Oncology, Inc.
Margaret is the Sr. Director of Computer Software Assurance for Taiho Oncology, Inc. where she led the transition of Taiho’s validation program from the traditional CSV to the CSA methodology in 2023. She also led Taiho’s conversion to paperless validation in 2024. Her current position is in the IT department, but she also has 25+ years’ experience in R&D and GxP environments in Pharma, OTC, Consumer Health, and Cosmetics. As a proven compliance leader, she has led Data Integrity, CSV and internal audits, as well as inspection readiness programs. Academically, she completed a BS in Biochemistry and Molecular Biology, MS in Chemistry, PhD in Bio-Organic Chemistry, and an MBA. She also holds certifications from ASQ for Quality Auditing and Quality Engineering, and has taken multiple online courses on Digital Transformation, Data Science, AI and AI governance. As a member of the FICSA team, she regularly presents at KENX and other webinars on CSA and other industry trends. Her ongoing professional interests are Validation Methodologies, Emerging Technologies (including AI and ML) and AI Governance.