Vishal Goyal Email & Phone Number

Information Technology Leader for autologous and allogenic Cell and Gene Therapy / Biotech space. Experience in R&D, Pre-Clinical, Clinical, CMC / PAD, Manufacturing, Vein-to-Vein, Quality, Regulatory, Medical and Commercial.Experience in solution selection, contract structuring, vendor management, implementation, computer system validation, and maintenance/support of Electronic Lab Notebook (ELN), Laboratory Information System (LIMS), Gxp / Non-GxP data storage / integration, Electronic Document Control (eDC), Electronic Trial Master File (eTMF), Clinical Trial Management System (CTMS), Quality Management System (QMS), Regulatory Information Management System (RIMS), Learning Management System (LMS), Digital / Document Asset Management System (DAM), Building Automation System (BAS), Environmental Monitoring System (EMS), Computerized Maintenance Monitoring Systems (CMMS), and Cell Orchestration System (COS). Experience with site technology set-up including network architecture, rack space, servers, data centers (Cloud and On-Prem), Access Controls, Data Security, and Cybersecurity.Key Accomplishments:Drug Development: Design and structured end-to-end information and data integration platform for the allogenic cell therapy process from healthy donor through patient administration.Research & Development: Enterprise evaluation, selection, and implementation of ELN / LIMS systems for complex allogenic processes integrated with OPC enabled lab equipment including bioreactors and CRFs.Quality & Regulatory: Defined and created IT Validation team (GxP systems) including process and policy for Computer System Validation (CSV), Periodic Reviews, Change Controls, CAPAs, and Deviations.Commercial & Medical: Successfully structured and replaced a manual global customer engagement process with a platform (Veeva). Program had $12M budget and over 1000 global users within 66 countries.

Listed skills include Project Management, Relationship Marketing, Cross Functional Team Leadership, Crm, and 13 others.