Hiring: Associate Director, Computer Systems Assurance (Quality) Company: Nurix Therapeutics Location: Brisbane, CA Job Posted Time: 2026-09-17 10:59:23 Employment Type: On-site Target Skills & Keywords : Agile, Change Management, SOC 2, SaaS, Systems Design, Vault About the job Experience: •10+ years of progressive experience in computer systems validation and/or computer systems assurance in a GxP-regulated pharmaceutical, biopharmaceutical, or biotechnology environment. Required Skills: •CSA Program Ownership and Strategy •Own and maintain Nurix's Computer Systems Assurance policy framework, SOPs, and risk-based validation strategy, aligned with FDA CSA guidance (2022), GAMP 5 (2nd edition), 21 CFR Part 11, EU Annex 11, and applicable ICH guidelines. •Define and implement a fit-for-purpose, risk-tiered approach to system qualification for SaaS and cloud-hosted GxP applications, recognizing the vendor-managed nature of modern software platforms. •Maintain the GxP system inventory; conduct and document periodic system risk assessments to classify systems and determine appropriate validation scope and rigor. •Establish and maintain processes for vendor assessment, including review of vendor SOC 2 reports, quality agreements, and audit strategies appropriate for SaaS providers. •Drive continuous improvement of the CSA program through benchmarking, regulatory intelligence, and adoption of industry best practices. •System Validation and Qualification Execution •Lead and execute validation activities for GxP SaaS platforms including, but not limited to, eQMS (e.g., Veeva Vault), electronic document management, clinical data management, regulatory information management, and laboratory information systems. Qualifications: •Bachelor's degree in computer science, information systems, life sciences, pharmaceutical sciences, or a related field. •7–10+ years of progressive experience in computer systems validation and/or computer systems assurance in a GxP-regulated pharmaceutical, biopharmaceutical, or biotechnology environment. •Demonstrated expertise in current regulatory requirements for computerized systems, including FDA 21 CFR Part 11, EU Annex 11, FDA CSA guidance (2022), and GAMP 5 (2nd edition). •Hands-on experience validating SaaS and cloud-hosted GxP platforms; understanding of vendor-managed environments and shared responsibility models. •Proficiency authoring and reviewing CSA/CSV deliverables: VMPs, URSs, Risk Assessments, IQ/OQ/PQ protocols, traceability matrices, and validation summary reports. •Strong working knowledge of data integrity principles (ALCOA+) and their application to electronic records management and GxP system design. •Demonstrated capacity to operate as both program owner and individual contributor in a lean, virtual organizational model; comfortable managing validation activities without a large internal support team. •Excellent written and verbal communication skills; able to translate complex technical and regulatory requirements into practical guidance for diverse stakeholders. •Strong organizational skills and attention to detail; demonstrated ability to manage multiple concurrent programs and priorities in a fast-paced environment. •Operational familiarity with clinical development platforms such as electronic data capture (EDC), regulatory information management (RIM), or clinical trial management systems (CTMS) in a validated context. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!