Senior IT Business Analyst, GLP & GMP

Role: Senior IT Business Analyst & GMP/GLP Systems Manager supporting Wave's GxP regulated systems in Quality Assurance and Regulatory Affairs. Responsibilities: elicit and document user needs, develop system requirements, lead validation and qualification of laboratory and manufacturing IT systems, ensure compliance with GxP and data integrity standards, manage change control, coordinate validation activities, and support audit readiness. Collaborate with QA, Reg Affairs, Manufacturing, Process Development, and external vendors; serve as IT liaison for regulated systems lifecycle activities. Requirements: BS/BA in Life Sciences, Engineering, or Information Systems; 8-12 years in business analysis, 5+ years supporting GxP environments; experience with computerized system validation (CSV), risk assessment, change management, and compliance standards including 21 CFR Part 11 and GAMP 5. Preferred: Master’s degree. High-Value: supporting GxP laboratory and manufacturing IT systems, validation, data integrity, inspection readiness, and cross-functional collaboration in biotech development. Location: onsite in Lexington, MA, with up to five days per week presence.