Senior IT Business Analyst, GLP & GMP
Wave Life Sciences
August 06, 2026
On-site
Greater Boston
IT
Responsibilities:
- Serve as primary business analysis partner for QA and Regulatory Affairs/Reg Ops for GxP computerized systems (e.g., QMS, quality documentation, submissions/labeling support tools).
- Elicit/document user needs; translate into system requirements; produce fit-for-purpose deliverables (user stories/use cases, process maps, data flow diagrams, configuration specs).
- Lead mid-to-large projects; ensure requirements are complete, testable, and traceable through validation and release.
- Support GLP/GMP qualification/validation (contribute to validation planning, risk assessment using GAMP 5; execute/ support IQ/OQ/PQ).
- Author/review key CSV deliverables (URS, configuration specs, traceability matrices, test scripts, summary reports) and ensure SOP/regulatory alignment.
- Coordinate controlled change management for patches/upgrades/config changes/integrations; embed qualification/validation considerations early.
- Maintain compliant system administration (access provisioning, least-privilege roles, access reviews), ensure backup/archiving/security.
- Support inspection readiness (evidence, traceability, change records), maintain ALCOA+ data integrity practices, retention/integrity monitoring.
- Train users on compliant use; perform related duties.
Qualifications/Experience:
- BS/BA in Information Systems, Life Sciences, Engineering, or related; Master’s preferred.
- 8–12 years IT systems business analysis.
- 5+ years supporting GLP/GMP environments with compliance/validation governance and inspection readiness.
- Hands-on CSV/CSA: requirements, risk/impact assessments, validation planning/testing support, change control, validated-state maintenance aligned with GAMP 5.
- Experience with audits/inspections and preparing validation evidence.
Key Skills:
- Strong GLP/GMP computerized systems knowledge (21 CFR Part 11, ALCOA+).
- Ability to translate regulatory/operational needs into compliant requirements; influence stakeholders/vendors without direct reports.
- Strong analytical/organizational/time-management and clear, audit-ready communication.
Benefits:
- Company-sponsored medical, dental, vision, life, long/short-term disability; generous paid time off (incl. week-long company shutdowns in summer and winter); 401(k) with matching; Employee Stock Purchase Program.
Work Location:
- Lexington, MA; onsite up to five days/week.
- Serve as primary business analysis partner for QA and Regulatory Affairs/Reg Ops for GxP computerized systems (e.g., QMS, quality documentation, submissions/labeling support tools).
- Elicit/document user needs; translate into system requirements; produce fit-for-purpose deliverables (user stories/use cases, process maps, data flow diagrams, configuration specs).
- Lead mid-to-large projects; ensure requirements are complete, testable, and traceable through validation and release.
- Support GLP/GMP qualification/validation (contribute to validation planning, risk assessment using GAMP 5; execute/ support IQ/OQ/PQ).
- Author/review key CSV deliverables (URS, configuration specs, traceability matrices, test scripts, summary reports) and ensure SOP/regulatory alignment.
- Coordinate controlled change management for patches/upgrades/config changes/integrations; embed qualification/validation considerations early.
- Maintain compliant system administration (access provisioning, least-privilege roles, access reviews), ensure backup/archiving/security.
- Support inspection readiness (evidence, traceability, change records), maintain ALCOA+ data integrity practices, retention/integrity monitoring.
- Train users on compliant use; perform related duties.
Qualifications/Experience:
- BS/BA in Information Systems, Life Sciences, Engineering, or related; Master’s preferred.
- 8–12 years IT systems business analysis.
- 5+ years supporting GLP/GMP environments with compliance/validation governance and inspection readiness.
- Hands-on CSV/CSA: requirements, risk/impact assessments, validation planning/testing support, change control, validated-state maintenance aligned with GAMP 5.
- Experience with audits/inspections and preparing validation evidence.
Key Skills:
- Strong GLP/GMP computerized systems knowledge (21 CFR Part 11, ALCOA+).
- Ability to translate regulatory/operational needs into compliant requirements; influence stakeholders/vendors without direct reports.
- Strong analytical/organizational/time-management and clear, audit-ready communication.
Benefits:
- Company-sponsored medical, dental, vision, life, long/short-term disability; generous paid time off (incl. week-long company shutdowns in summer and winter); 401(k) with matching; Employee Stock Purchase Program.
Work Location:
- Lexington, MA; onsite up to five days/week.