Senior IT Business Analyst – GLP/GMP Systems Manager

About the role

Support GxP-regulated computerized systems, with a focus on Quality Management Systems (QMS), quality documentation, and laboratory and manufacturing platforms.

Tasks

• Partner with #QA and #RA/Reg Ops to gather, prioritize, and document business requirements for #GxP computerized systems, including Veeva Vault and related quality platforms.
• Lead requirements-gathering workshops and develop user stories, use cases, process maps, data flow diagrams, and configuration specifications.
• Manage medium- to large-scale projects with significant business impact, ensuring alignment between IT solutions and business objectives.
• Support Computerized System Validation (#CSV), including validation planning, risk assessments, requirements traceability, and #IQ/OQ/PQ activities.

Requirements

• 8–12 years of experience in Information Systems business analysis.
• 5+ years of experience supporting #GxP-regulated environments, including #GLP and #GMP, with a focus on compliance, validation governance, and inspection readiness.
• Hands-on experience with Computerized System Validation (#CSV), requirements definition, risk and impact assessments, validation testing, change control, and maintaining validated systems.
• Knowledge of #GAMP 5, regulatory requirements, internal quality procedures, and data integrity principles.
• Experience analyzing laboratory, quality, manufacturing, facilities, or process development workflows and translating business needs into compliant system requirements.

Location

• Boston, MA