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Nancy Sutter has a strong background in computer system validation and software development life cycle (SDLC) documentation. Nancy has worked as a Software Validation Lead at Pharmaron since November 2018, where they collaborate with system and equipment owners to manage validation documentation. Prior to that, they were a Computer System Validation (CSV) Lead for Enterprise Quality Systems at Shire from 2014 to 2018, responsible for implementing risk-based validated implementations and migrating Legacy Baxalta's platforms. From 2010 to 2014, Nancy served as a Senior Validation Consultant at Jacquette Consulting, where they led upgrades to Shire's Regulatory Submission system and developed the company's first IT System Integration process. Nancy also has experience as a Senior Computer System Validation Lead at Pfizer (formerly Wyeth Pharmaceuticals), where they managed validation deliverables and technical application support for ISOtrain.

Nancy Sutter holds a Bachelor of Social Work and Psychology (B.S.W.) degree from Kean University. In 2018, they obtained additional certifications in GDPR Compliance: Essential Training and Scrum: The Basics from LinkedIn.