Senior IT Business Analyst - GxP Systems & Validation

Wave Life Sciences; Massachusetts; On-site; USD 127,000 - 172,000; Full time

Job summary

Wave Life Sciences in Lexington, MA is seeking a Senior IT Business Analyst, GLP and GMP Systems Manager to support QA and Regulatory Operations, ensuring compliant data handling across QMS and related platforms. This role represents IT in GxP lifecycle activities and coordinates validation, data integrity, and secure data storage.

You will elicit user needs, translate them into system requirements, and drive validation activities, ensuring readiness for inspections and audits while maintaining

Qualifications

• Bachelor's degree in a relevant field and 8–12 years in information systems business analysis.
• 5+ years in GLP/GMP environments with validation governance and inspection readiness.
• Experience with computerized system validation (CSV) and CSA activities, including documentation and traceability.

Responsibilities

• Serve as the primary BA for QA and Reg Affairs/Reg Ops for GxP systems.
• Lead requirements elicitation and produce user stories, process maps, and data-flow diagrams.
• Oversee mid-to-large projects with significant business impact.
• Coordinate validation activities and ensure traceability from requirements to testing and release.
• Coordinate change control for patches, upgrades, and integrations.
• Support inspection readiness and data integrity for regulated platforms.

Skills

GxP knowledge

CSV/CSA

Validation governance

Audit/inspection support

Regulatory liaison

Education

BS/BA in Information Systems, Life Sciences, Engineering

MS preferred

Job description

Wave Life Sciences in Lexington, MA is seeking a Senior IT Business Analyst, GLP and GMP Systems Manager to support QA and Regulatory Operations, ensuring compliant data handling across QMS and related platforms. This role represents IT in GxP lifecycle activities and coordinates validation, data integrity, and secure data storage.

You will elicit user needs, translate them into system requirements, and drive validation activities, ensuring readiness for inspections and audits while maintaining