Krista Woodley

Sr Director IT - Quality, Supply Chain and Digital Assurance @Thermo Fisher Scientific

Boston, MA, US

EMAILS

[email protected]

MOBILE NUMBERS

+91 *********19

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WORK HISTORY

Mar 2025 — Present

Sr Director IT - Quality, Supply Chain and Digital Assurance @Thermo Fisher Scientific

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Waltham, MA, US

IT Business Partner for Pharma Services - Quality and Supply Chain/ERP and responsible for PSG IT’s Digital Assurance function.

EDUCATION

1997 — 1999

Weatherhead School of Management at Case Western Reserve University

Master of Business Administration - MBA, Operations, Information Technology

1990 — 1994

Miami University

Bachelor of Arts - BA, Zoology

SKILLS

Risk ManagementLimsSoxGood Laboratory Practice (Glp)Computer System ValidationV&VQuality Assurance21 Cfr Part 11Verification and Validation (V&V)Sap R/3IT ManagementDrug DevelopmentGcpBiopharmaceuticalsU.s. Food and Drug Administration (Fda)Sarbanes-Oxley ActManagement ConsultingMedical DevicesCapaGmpSoftware Development Life Cycle (Sdlc)FormulationValidationLaboratory Information Management System (Lims)Process ImprovementCross-Functional Team LeadershipGampPharmaceutical IndustryBusiness Process ImprovementSopFdaManagementCorrective and Preventive Action (Capa)Quality ManagementLife SciencesSoftware DocumentationU.s. Title 21 Cfr Part 11 RegulationSoftware Quality AssuranceChange ControlStandard Operating Procedure (Sop)

ABOUT KRISTA WOODLEY

A results-driven Digital Health, Medical Technology and Pharma Quality executive with over twenty years in the healthcare industry, focusing on leading digital transformation initiatives for global pharma, biotechnology, and medical device companies. Recognized for designing and implementing quality organizations that focus on delivering new and innovative technologies which streamline business operations and improve health outcomes for patients worldwide. Recognized for generating strategic insights and driving effective business results while continuously building in improvements to advance product lifecycle management practices and solution delivery. A versatile leader that continuously creates an environment that fosters collaborative teamwork within and across functions.

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