Senior GxP Systems Analyst - GLP/GMP, QA Partner

Katalyst CRO; Boston (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

Wave's Senior IT Business Analyst, GLP and GMP Systems Manager, leads business analysis and IT support for GxP computer systems across QA and RA/Reg Ops. You elicit stakeholder needs, translate to system requirements, and ensure solutions are qualified, validated, and maintained in a compliant state.

You represent IT in lifecycle activities for QMS and quality documentation, coordinating data integrity, security, and inspection readiness.

Qualifications

• Bachelor's degree in Information Systems, Life Sciences, Engineering; 8–12 years in information systems business analysis; 5+ years in GxP environments; experience with computerized system validation (CSV).
• Hands-on experience partnering with QA, RA/Reg Ops, IT, and vendors to ensure regulatory and data integrity.
• Experience supporting audits/inspections, including validation evidence, SOP alignment, and auditor inquiries related to system use and controls.

Responsibilities

• Serve as primary business analysis partner for QA and RA/Reg Ops supporting GxP systems including intake, triage, and prioritization of enhancements and defects.
• Lead requirements elicitation (workshops/interviews) and produce user stories, data flow diagrams, and configuration specs.
• Oversee mid to large-scale projects with significant business impact.
• Ensure requirements are complete, testable, and traceable through validation testing and release.
• Provide systems qualification/validation support for GLP and GMP systems and contribute to validation planning and risk assessment.
• Author/review CSV deliverables (URS, traceability matrices, test scripts) and ensure SOP alignment.
• Coordinate change management for patches, upgrades, configuration changes, and integrations.
• Maintain best practices for data integrity and ensure validation evidence is readily retrievable for GLP/GMP systems.

Skills

GxP regulatory knowledge

CSV (Computerized System Validation)

Business process analysis

Stakeholder management

Documentation & traceability

QA collaboration

Regulatory compliance

Project coordination

Education

Bachelor's degree in Information Systems, Life Sciences, Engineering

Master's degree preferred

Job description

Wave's Senior IT Business Analyst, GLP and GMP Systems Manager, leads business analysis and IT support for GxP computer systems across QA and RA/Reg Ops. You elicit stakeholder needs, translate to system requirements, and ensure solutions are qualified, validated, and maintained in a compliant state.

You represent IT in lifecycle activities for QMS and quality documentation, coordinating data integrity, security, and inspection readiness.