Senior IT Business Analyst, GLP & GMP
Wave Life Sciences
June 24, 2026
On-site
Greater Boston
IT
Responsibilities:
- Serve as a primary business analysis partner for QA and Regulatory Affairs/Reg Ops teams supporting GxP computerized systems (e.g., QMS, quality documentation, submissions/labeling support tools), including intake, triage, and prioritization of enhancements, defects, and lifecycle needs.
- Lead requirements elicitation (workshops, interviews) and produce user stories/use cases, process maps, data flow diagrams, and configuration specifications.
- Oversee mid to large-scale projects.
- Partner with QA/Validation to ensure requirements are complete, testable, and traceable through the lifecycle (user needs → validation testing → release).
- Support GLP/GMP systems qualification/validation, including validation planning, risk assessment (e.g., GAMP 5), and execution support for IQ/OQ/PQ.
- Author/review key CSV deliverables (URS, configuration specs, traceability matrices, test scripts, summary reports).
- Coordinate controlled change management for patches, upgrades, configuration changes, and integrations.
- Maintain compliant system administration (user access provisioning, roles/permissions, access reviews) and ensure security, backup, archiving, and inspection readiness.
- Establish best practices for data integrity (ALCOA+), storage, retention, and integrity monitoring; coordinate periodic review of validated systems.
- Train IT and business users on compliant use of qualified/validated computerized systems.
Qualifications:
- Bachelor’s degree (BS/BA) in Information Systems, Life Sciences, Engineering, or related; Master’s preferred.
- 3–5 years in information systems business analysis.
- 3+ years supporting GxP-regulated (GLP/GMP) environments with compliance/validation governance and inspection readiness.
- Hands-on CSV/CSA experience aligned with GAMP 5: requirements, risk/impact assessments, validation planning, testing support, change control, maintaining validated state.
- Ability to translate regulatory/operational needs into compliant requirements; partner with QA, SMEs, IT, and vendors.
- Experience supporting audits/inspections and preparing validation evidence.
Key Skills:
- GLP/GMP computerized systems knowledge (21 CFR Part 11, ALCOA+), risk-based validation aligned with GAMP 5.
- Strong analytical, organizational, time-management, and audit-ready communication skills.
Benefits (as stated):
- Base salary $127,000–$172,000; discretionary bonus and stock-based long-term incentives.
- Comprehensive benefits including medical/dental/vision/life/long & short-term disability, paid time off (incl. week-long shutdown in Summer and Winter), 401(k) with matching, and Employee Stock Purchase Program.
Work location:
- Lexington, MA office; onsite up to five days per week.
- Serve as a primary business analysis partner for QA and Regulatory Affairs/Reg Ops teams supporting GxP computerized systems (e.g., QMS, quality documentation, submissions/labeling support tools), including intake, triage, and prioritization of enhancements, defects, and lifecycle needs.
- Lead requirements elicitation (workshops, interviews) and produce user stories/use cases, process maps, data flow diagrams, and configuration specifications.
- Oversee mid to large-scale projects.
- Partner with QA/Validation to ensure requirements are complete, testable, and traceable through the lifecycle (user needs → validation testing → release).
- Support GLP/GMP systems qualification/validation, including validation planning, risk assessment (e.g., GAMP 5), and execution support for IQ/OQ/PQ.
- Author/review key CSV deliverables (URS, configuration specs, traceability matrices, test scripts, summary reports).
- Coordinate controlled change management for patches, upgrades, configuration changes, and integrations.
- Maintain compliant system administration (user access provisioning, roles/permissions, access reviews) and ensure security, backup, archiving, and inspection readiness.
- Establish best practices for data integrity (ALCOA+), storage, retention, and integrity monitoring; coordinate periodic review of validated systems.
- Train IT and business users on compliant use of qualified/validated computerized systems.
Qualifications:
- Bachelor’s degree (BS/BA) in Information Systems, Life Sciences, Engineering, or related; Master’s preferred.
- 3–5 years in information systems business analysis.
- 3+ years supporting GxP-regulated (GLP/GMP) environments with compliance/validation governance and inspection readiness.
- Hands-on CSV/CSA experience aligned with GAMP 5: requirements, risk/impact assessments, validation planning, testing support, change control, maintaining validated state.
- Ability to translate regulatory/operational needs into compliant requirements; partner with QA, SMEs, IT, and vendors.
- Experience supporting audits/inspections and preparing validation evidence.
Key Skills:
- GLP/GMP computerized systems knowledge (21 CFR Part 11, ALCOA+), risk-based validation aligned with GAMP 5.
- Strong analytical, organizational, time-management, and audit-ready communication skills.
Benefits (as stated):
- Base salary $127,000–$172,000; discretionary bonus and stock-based long-term incentives.
- Comprehensive benefits including medical/dental/vision/life/long & short-term disability, paid time off (incl. week-long shutdown in Summer and Winter), 401(k) with matching, and Employee Stock Purchase Program.
Work location:
- Lexington, MA office; onsite up to five days per week.