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.
• Support software change requests from initiation through closure, including risk assessment, implementation and backout planning, test evidence, deviation resolution, and final approval routing.
• Maintain systems in a validated state through periodic reviews, revalidation assessments, retirement/decommissioning activities, and verification that system and validation documentation remains current.

CSV Governance and Portfolio Oversight

• Maintain the computerized system inventory, validation status, validation schedules, periodic review calendar, open action tracking, and inspection-ready validation repositories.
• Develop and improve CSV templates, procedures, work instructions, standards, and metrics consistent with CG Oncology quality systems and a risk-based GAMP 5/CSA approach.
• Track validation risks, issues, dependencies, resource needs, and milestones across multiple concurrent projects and escalate barriers promptly.

Supplier and Vendor Qualifications

• Support supplier qualification and risk assessment by reviewing vendor quality systems, SDLC practices, release documentation, validation packages, security/compliance evidence, and service controls.
• Coordinate validation deliverables, defect resolution, release impact information, and testing support with SaaS providers, implementation partners, consultants, and other third parties.

Inspection Readiness and Quality Support

• Maintain audit-ready documentation and support internal audits, regulatory inspections, partner audits, due diligence, and health authority requests related to computerized systems.
• Support investigation and remediation of validation deviations, system defects, data integrity concerns, CAPAs, and audit observations, including effectiveness checks where assigned.
• Evaluate controls related to electronic records and signatures, audit trails, user access, security, backup/restore, business continuity, and data migration as part of validation activities.

Cross-Functional Partnership and Training

• Facilitate requirements, risk assessment, test planning, and validation review sessions with business and technical stakeholders.
• Provide practical CSV guidance and training to System Owners, Business Owners, administrators, testers, and project teams; coach contributors on evidence quality and good documentation practices.
• Serve as a trusted CSV subject matter resource who balances business urgency with patient safety, product quality, data integrity, and regulatory expectations.

Qualifications

• Bachelor's degree in information technology, computer science, engineering, life sciences, quality, or a related discipline; equivalent education and experience may be considered.
• Five or more years of progressive experience in computer systems validation, quality systems, IT quality, or regulated systems within biotechnology, pharmaceutical, medical device, or another life sciences environment.
• At least three years of direct experience authoring and executing CSV lifecycle deliverables for GxP computerized systems.
• Experience validating SaaS/cloud, configured, and/or custom applications using a risk-based approach.
• Working knowledge of 21 CFR Part 11, GxP data integrity expectations, GAMP 5, SDLC, change control, and good documentation practices.
• Experience with requirements, risk assessments, traceability, scripted testing/UAT, deviations, validation reports, periodic reviews, and release/change impact assessments.
• Demonstrated ability to work with business owners, QA, IT, vendors, and project teams to deliver compliant systems on schedule.

Please note that CG Oncology does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Any resumes or client information submitted to our careers page or any employee of CG Oncology by any search firm or agency without an applicable contract in place will become the property of CG Oncology and no fee(s) will be paid.

Total Rewards

CG Oncology offers very competitive and comprehensive Total Rewards, helping to support and reward our global team of high-performing employees focused on developing bladder-saving therapeutics for patients afflicted with bladder cancer.

• HIGHLY COMPETITIVE SALARIES
• ANNUAL PERFORMANCE/MERIT REVIEWS
• ANNUAL PERFORMANCE BONUSES
• EQUITY
• SPECIAL RECOGNITION

Well-Being Benefits

In addition to our Total Rewards, CG Oncology offers a variety of Well-Being Benefits to meet the majority of the needs of our unique and growing workforce. These benefits are designed to support our team to achieve a healthy balance between work and their personal lives to remain refreshed, engaged, and creating an environment where each person can find a deeper meaning and purpose in their work.

Well-Being Benefits eligibility begins the 1st of the month after hire. While a majority of these benefits are for our US-based workforce, we continue to assess comparable levels of benefits for our international team members that are aligned with country-specific regulations and their national programs offered.

• FULLY REMOTE WORK ENVIRONMENT
• REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off
• HOLIDAYS -In 2026 we will observe 14 holidays
• RETIREMENT - 401K with 100% company Safe Harbor match up to 4% of base salary
• HEALTH (MEDICAL, DENTAL, VISION) - PPO & HDHP - Cigna/Principal
• HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC
• ILLNESS & DISABILITY PROTECTION - Company Paid LTD Coverage + Voluntary Plans
• LIFE INSURANCE - Company Paid 1 x base salary + Voluntary Plans
• ADDITIONAL EXCLUSIVE BENEFITS - Voluntary Legal, Pet, Plus More