Senior IT Business Analyst, GLP & GMP

Role: Senior IT Business Analyst and Systems Manager supporting GxP-regulated laboratory and manufacturing systems within Wave Life Sciences' biopharma environment. Objectives include ensuring compliance, data integrity, and validation of computerized systems supporting quality and regulatory functions. Responsibilities encompass eliciting user requirements, leading validation efforts aligned with GAMP 5, managing change controls, supporting audits, and maintaining inspection readiness. The role involves close collaboration with QA, Regulatory Affairs, Manufacturing, and external vendors, with a focus on quality documentation, system lifecycle management, and data security. Requirements: Bachelor’s in Information Systems, Life Sciences, Engineering, or related; 8-12 years’ experience in business analysis and 5+ years supporting GLP/GMP environments; strong knowledge of 21 CFR Part 11, ALCOA+ data principles, and validation practices. Preferred: Master’s degree, prior validation experience with laboratory and manufacturing IT systems, and ability to influence cross-functional teams. HighValue: supporting regulated systems throughout their lifecycle, validation and compliance expertise, GxP systems in biotech, handling audits and inspection readiness, focus on data integrity, and collaboration with QA and regulatory teams. WorkSetup: Onsite in Lexington, MA, with up to five days per week presence.