Associate Director, Computer Systems Assurance (Quality)

Responsibilities

• 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.
• Author and review validation documentation including Validation Master Plans (VMPs), User Requirements Specifications (URS), Risk Assessments, Vendor Assessments, Validation Protocols (IQ/OQ/PQ), Traceability Matrices, and Validation Summary Reports.
• Manage validation activities associated with system implementations, major configuration changes, upgrades, and periodic re-validation reviews, applying critical thinking to scope validation effort proportionate to system risk and change impact.
• Coordinate validation testing activities with cross-functional stakeholders; ensure test scripts are appropriately designed to demonstrate fitness for intended use.
• Review and approve validation deliverables prepared by internal teams, vendors, or external validation consultants.
• 21 CFR Part 11 and Data Integrity
• Serve as the internal subject matter expert for 21 CFR Part 11 and EU Annex 11 requirements; assess systems for compliance and provide guidance to cross-functional partners.
• Partner with IT and system owners to ensure electronic records and electronic signature controls are properly implemented and documented in all GxP systems.
• Support data integrity asses

Benefits

Additional Information

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix's dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine's next chapter with a new script to outmatch disease. Position The Senior Manager / Associate Director, Computer Systems Assurance (CSA) is an important technical and operational leader within the Nurix Quality Systems organization, responsible for owning and advancing Nurix's computer systems assurance program. As a virtual drug developer, Nurix operates through a lean internal infrastructure and relies on a curated ecosystem of Software-as-a-Service (SaaS) and cloud-hosted platforms to support GxP-regulated activities across clinical development, quality operations, manufacturing oversight, and regulatory submissions. This role will serve as the primary subject matter expert and program owner for all CSA and computerized system validation (CSV) activities at Nurix. Reporting to the Vice President / Senior Director, Quality Systems, this individual will establish and maintain Nurix's risk-based CSA framework aligned with current regulatory expectations, including the FDA's 2022 guidance on computer software assurance, GAMP 5 (2nd edition), and applicable 21 CFR Part 11 and Annex 11 requirements. The role requires an individual who combines deep technical knowledge of GxP computerized systems with practical experience in SaaS and cloud-based platform qualification, and who can translate regulatory requirements into pragmatic, fit-for-purpose validation approaches that support a modern, agile biotech environment. This is a high-impact, program-ownership role requiring both strategic vision and hands-on execution. The successful candidate will work closely with Quality, IT, Regulatory Affairs, CMC, Clinical Operations, and external vendors to ensure that all GxP-critical systems are appropriately assessed, validated, and maintained in a compliant state. The individual will champion a risk-based, science-driven approach to CSA across the organization.

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