GPO Computer System Validation, BD
Roy is the (GPO-CSV) Global Process Owner for Computer systems validation; GPO (e-systems, e-data management and cybersecurity) Heads validation and compliance team as part of Global IT.
AT BD, Roy is 3 years into a 5-year Enterprise-wide initiative to harmonize and align QMS systems, focusing on rationalizing 9 policies & 65+ procedures for CSV into 1 Policy and 4 procedures as the foundation of a simplified Risk based approach for CSV.
Prior to joining BD in July, 2016, Roy previously served 9 years as the Global Consulting Practice lead for 2 international consulting firms, before that he spent 12 years as an independent consultant to Tier 1 pharma companies in Advanced Clinical R&D and Safety information systems. Key experiences included. leading Clinical, Pharmacovigilance and Reg affairs strategic program development, eTMF development, Regulatory Intelligent services. He started his career in Merck as Development Architect for remote data capture. Roy earned a BS degree in Information Decisions Systems from CMU in Pittsburg.