Senior IT Business Analyst

Position Summary

Our client is seeking a Senior IT Business Analyst to support GxP-regulated systems across Quality, Regulatory Affairs, Manufacturing, and Laboratory Operations. This role serves as the primary liaison between business stakeholders and IT, ensuring compliant, validated technology solutions that support critical business operations.

The ideal candidate brings extensive experience in CSV, CSA, GAMP 5, and regulated life sciences environments.

Responsibilities

• Partner with Quality, Regulatory, Manufacturing, Facilities, and IT teams to support GxP-regulated systems.
• Gather, analyze, and document business and system requirements.
• Lead business analysis activities for system implementations, enhancements, and upgrades.
• Support Computerized System Validation (CSV) and Computer Systems Assurance (CSA), including requirements, risk assessments, validation planning, testing, and change control.
• Author and review validation documentation, including URS, traceability matrices, test scripts, and validation reports.
• Coordinate system changes, upgrades, integrations, and lifecycle activities while maintaining validated status.
• Support inspection readiness by maintaining complete, audit-ready documentation.
• Partner with stakeholders and vendors to improve business processes and system performance.
• Develop process improvements and technology roadmaps aligned with business objectives.
• Promote data integrity, compliance, and GxP best practices.
• Train users on validated systems and related procedures.

Qualifications

• Bachelor's degree in Information Systems, Engineering, Life Sciences, or a related field required.
• Master's degree preferred.
• 8+ years of IT Business Analysis experience.
• 5+ years supporting GLP/GMP-regulated environments.
• Hands-on experience with CSV, CSA, GAMP 5, and validation governance.
• Experience supporting laboratory, quality, manufacturing, or regulatory systems.
• Strong knowledge of 21 CFR Part 11, ALCOA+, and data integrity principles.
• Experience supporting regulatory audits and inspections.
• Excellent communication, analytical, and stakeholder management skills.