Director, GTS Quality Systems

Role: Director of Quality Systems, overseeing global technology operations and deployment of enterprise QMS platforms, primarily Veeva Quality applications, within a biopharma setting. Objectives include ensuring compliant, scalable Quality technology solutions aligned with GxP and data integrity standards. Responsibilities: lead GTS delivery and support for QMS systems, manage application operations, coordinate vendor and project management, translate business needs into technical plans, support validation and CSA deliverables, and oversee system enhancements across Quality processes such as document control, deviations, CAPA, change control, and audits. Manage budgets, demand, and roadmaps; collaborate with Global Quality, site Quality, GTS teams, and vendors; and supervise a team of three. Qualifications: bachelor’s degree in Engineering, Computer Science, or related field with 7+ years of experience (or master’s degree with 5+ years) in supporting Quality systems; hands-on experience with Veeva Quality applications and Quality GxP processes; knowledge of 21 CFR Part 11, data integrity, validation, and CSA. Preferred: experience with Validation Management Systems, Inspection Management, AI tools, and other regulated Quality systems. Work setup: primarily remote with less than 20% domestic/international travel. Emphasis on cross-functional collaboration, vendor management, and ensuring validated, compliant systems to support Quality business needs.