Senior Analyst, Computer Systems Validation

**About CG Oncology, Inc.** Are you ready to make a difference in the world and become part of our patient\-centered team that is focused on Attacking Bladder Cancer for a Better Tomorrow? At CG Oncology, we believe that by having exceptionally talented individuals on our team who share our passion and enjoy working together, we can truly achieve our Vision and Mission to benefit patients around the world. Every day we are making significant advancements across our multiple pipelines and are growing rapidly to meet the needs of our patients who cannot afford to wait to benefit from our novel immunotherapies. Please review this job posting and our Values and if they resonate with you and are what you expect from your organization and team, then we would like to hear from you. **About the role** The Senior Analyst, Computer Systems Validation (CSV) is an individual contributor within Information Technology responsible for planning, authoring, coordinating, and executing risk\-based validation and system lifecycle activities for CG Oncology computerized systems used in regulated GxP operations. The role supports new implementations, configurations, upgrades, integrations, data migrations, vendor releases, periodic reviews, revalidation, and system retirement. The Senior Analyst partners with IT, Quality Assurance, System Owners, Business Owners, subject matter experts, and external vendors to produce fit\-for\-purpose, inspection\-ready validation evidence while maintaining practical controls and appropriate separation of duties. The role leads day\-to\-day CSV execution and coordination; Quality Assurance provides independent compliance oversight and required approvals. **Essential Functions** Validation Planning and Execution* Perform or support GxP applicability, 21 CFR Part 11, software categorization, and validation impact assessments for new and existing computerized systems. * Develop risk\-based validation strategies, plans, schedules, and deliverable matrices appropriate to system complexity, intended use, patient/product risk, and data integrity impact. * Author, review, and maintain validation deliverables, including user and functional requirements, risk assessments, traceability matrices, test plans and scripts, installation/operational/performance qualification or UAT documentation, deviation records, and validation summary reports. * Coordinate and execute qualification and user acceptance testing; confirm test evidence is complete, attributable, legible, contemporaneous, original, accurate, and independently reviewed as required. * Leverage supplier documentation and testing where justified, documenting the rationale and any supplemental CG Oncology verification required. Change, Release, and Lifecycle Management* Assess configuration changes, vendor releases, patches, defects, integrations, interfaces, and data migrations to determine validation impact, testing scope, documentation needs, and implementation controls. *