Kevin DeLeon

Principal Consultant

Kevin has worked for nearly 30 years at the juncture of information technology and regulatory compliance to develop, validate, implement and provide quality oversight of a broad range of GxP application, laboratory, manufacturing, and packaging systems.  He has a strong compliance background in Data Integrity, Part 11/Annex 11, associated GMPs with broad experience in IT quality oversight, IT QMS, auditing, GAMP-based CSV and SDLC.       

Prior to joining CREO, Kevin was a Global Quality Manager with Catalent where he established and managed the corporate Data Integrity Program with ongoing rollouts and training to over 30 sites, refined global IT Quality and CSV procedures, performed internal IT/CSV/DI site audits, performed IT supplier audits, and provided quality oversight to global LIMS, CDS, QMS, MES, Serialization, ERP and other core pharmaceutical system implementations, site rollouts, and upgrades.  He refined and provided oversight of the IT QMS system including IT change controls, system periodic reviews, audits, investigations, deviations and CAPAs. 

Kevin has provided IT quality leadership, oversight and compliance training to numerous global cross-functional and offshore project teams including business owners, system owners, IT infrastructure, CSV, developers, vendors, and consultants.  He has faced or provided responses to numerous regulatory agency and client auditors.  He has also provided quality oversight for data center migrations, site acquisitions and divestitures.    

Kevin earned his Bachelor of Arts in Management Information Systems from Texas State University and is a member of the International Society for Pharmaceutical Engineering (ISPE).

Areas of Focus

IT Quality Compliance and QMS
Data Integrity and CSV
GxP Systems