GxP IT Business Analyst – GLP/GMP & Validation Lead

Wave Life Sciences; Lexington (MA); On-site; USD 127,000 - 172,000; Full time

Job summary

Wave Life Sciences in Lexington, MA is seeking a Senior IT Business Analyst to support GLP/GMP systems and QA/regulatory operations. You will elicit user needs, translate them into clear requirements, and ensure qualified, validated solutions remain compliant across QMS and related tools.

You will partner with QA,Reg Ops, and IT to drive validation planning, risk assessments, and inspection readiness, including CSV artifacts and change control. Onsite work up to five days/week is expected.

Qualifications

• Bachelor's degree in Information Systems, Life Sciences, Engineering or related field; Master’s preferred.
• 8-12 years of information systems business analysis experience.
• 5+ years supporting GxP-regulated environments with emphasis on validation and inspection readiness.
• Hands-on CSV/CSA activities including requirements, risk assessments, validation planning, testing, and change control.
• Experience translating regulatory and operational needs into compliant system requirements.
• Ability to partner with QA, IT, and external vendors to meet regulatory/data integrity expectations.

Responsibilities

• Serve as primary business analysis partner for QA and Reg Ops on GxP systems (QMS, quality documentation, submissions tools).
• Lead requirements elicitation (workshops/interviews) and produce user stories, process maps, data flows, and specs.
• Oversee mid-to-large projects with significant business impact.
• Collaborate with QA/Validation to ensure testability and traceability through lifecycle.
• Provide CSV qualification/validation support for GLP and GMP systems (IQ/OQ/PQ).
• Create and review CSV deliverables (URS, specs, traceability matrices, test scripts).
• Coordinate change management for patches, upgrades, and integrations.
• Ensure data integrity, access control, and regulatory alignment across systems.
• Train users and support inspection readiness with audit-ready documentation.
• Develop strategic roadmaps aligning IT with business goals.

Skills

GxP experience

CSV validation

QA collaboration

Regulatory compliance

Requirements elicitation

Data integrity

Audit readiness

Process analysis

SOP alignment

Education

BS/BA in Information Systems, Life Sciences, Engineering

Master’s degree preferred

Tools

QMS software

Document management systems

Job description

Wave Life Sciences in Lexington, MA is seeking a Senior IT Business Analyst to support GLP/GMP systems and QA/regulatory operations. You will elicit user needs, translate them into clear requirements, and ensure qualified, validated solutions remain compliant across QMS and related tools.

You will partner with QA,Reg Ops, and IT to drive validation planning, risk assessments, and inspection readiness, including CSV artifacts and change control. Onsite work up to five days/week is expected.