Note: The job is a remote job and is open to candidates in USA. CG Oncology is focused on Attacking Bladder Cancer for a Better Tomorrow and is seeking a Senior Analyst in Computer Systems Validation. The role involves planning, authoring, coordinating, and executing risk-based validation and system lifecycle activities for computerized systems used in regulated GxP operations.
Responsibilities
- 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
- 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
- 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
- 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
- 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
- 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
Skills
- 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
Benefits
- ANNUAL PERFORMANCE/MERIT REVIEWS
- ANNUAL PERFORMANCE BONUSES
- EQUITY
- SPECIAL RECOGNITION
- 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
- Well-Being Benefits eligibility begins the 1st of the month after hire.
Company Overview
Company H1B Sponsorship