Andrew Martin
Director of Quality Systems and Engineering @Enveda
Signup · Get unlimited contacts
WORK HISTORY
Director of Quality Systems and Engineering @Enveda
Director of Quality Systems and Engineering at Enveda, focused on building the infrastructure and tools that make regulated quality work faster, more traceable, and more scalable through AI and automation.What I\'ve been building: Enterprise AI Quality PlatformDesigned and built an enterprise AI application that automates regulated document generation from scratch. Audit reports, Computer System Validation packages, and batch review and disposition workflows that once took 24 to 40+ hours now take minutes. Built with full source traceability, a 414-test IQ/PQ automated test suite, and a human-in-the-loop architecture purpose-built for regulated environments. CMC AI and Automation WorkflowsDeveloped end-to-end CMC workflows powered by AI, with Box as the core infrastructure. This includes automated document classification pipelines, extraction templates, folder architecture frameworks, and integration tooling to make CMC documentation more efficient and audit-ready. GxP Computer System ValidationLed the onboarding and formal validation of Enveda\'s GxP systems portfolio including Veeva (eTMF/CTMS), Endpoint Clinical (RTSM), Castor (eCOA), and Box, each evaluated through a formal risk classification framework. GxP Quality InfrastructureBuilt Enveda\'s quality systems foundation from the ground up, including SOPs and policies covering SDLC and CSV, change control, account management, data integrity, electronic records and signatures, AI use in GxP, and system risk classification.
EDUCATION
San José State University
Bachelor's degree, Chemistry (conc. Biochem)
SKILLS
ABOUT ANDREW MARTIN
Visionary IT Leader specializing in enterprise applications and business systems within GxP environments for biotech and biopharma. Over 15 years of proven success managing QMS, LIMS, ERP, LMS, and CDS systems, building high performing teams, driving strategic IT roadmaps, ensuring regulatory compliance, and delivering significant operational and cost efficiencies. Passionate about enabling science through transformative technology solutions.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.