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Randall Downs Location
Chapel Hill, NC, US
Randall Downs Work
IT PMO and GxP Program Management Consultant for Pharma and Biotech industries @ PrO Consulting (September 2025 - Present)
IT PMO Director - Aligned to Regulatory Affairs, Global Compliance and QA, and Corporate IT services @ (March 2017 - November 2024)
R and D IT Program Director @ (January 2013 - June 2016)
R and D IT Program Manager @ (January 2009 - January 2012)
R and D IT Senior PM @ (January 2007 - January 2009)
R and D IT Softwared Development Manager @ (January 2001 - January 2006)
Randall Downs Education
New Jersey Institute of Technology
Master of Science (Software Engineering)
University of North Carolina at Greensboro
Bachelor of Science (Mathematics, Computer Science)
Randall Downs Skills
21 CFR Part 11
Budgets
Business Analysis
Business Process Improvement
CRO
Change Control
Change Management
Clinical Trials
Computer System Validation
Cross-functional Team Leadership
Data Analytics
GCP
Integration
Leadership
Life Sciences
Management
Mentoring
Pharmaceutical Industry
Process Improvement
Program Development
Program Management
Project Management
Project Portfolio Management
SDLC
Software Development Life Cycle (SDLC)
Software Project Management
U.S. Title 21 CFR Part 11 Regulation
Validation
Software Project
Project Portfolio
Cross Functional Team
Cross Functional Team Leadership
Computer System
Software Development Life Cycle Sdlc
Software Development Life Cycle
Randall Downs Summary
Randall Downs, based in Chapel Hill, NC, US, is currently a IT PMO and GxP Program Management Consultant for Pharma and Biotech industries at PrO Consulting . Randall Downs brings experience from previous roles at ICON plc, GlaxoSmithKline and GSK. Randall Downs holds a Master of Science in Software Engineering @ New Jersey Institute of Technology. With a robust skill set that includes 21 CFR Part 11, Budgets, Business Analysis, Business Process Improvement, CRO and more.
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