Nurix Therapeutics

Nurix Therapeutics

Associate Director, Computer Systems Assurance (Quality)

Brisbane, CA · Director

Sponsorship not specified$171k-$193kDetected 3 days ago
CybersecurityCompliancePatient CareFDA RegulatoryCommunicationCritical ThinkingOrganizational SkillsGxPRegulatory Affairs

About the role

  • 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.
  • This role will serve as the primary subject matter expert and program owner for all CSA and computerized system validation (CSV) activities at Nurix.
  • This is a high-impact, program-ownership role requiring both strategic vision and hands-on execution.

Responsibilities

  • 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.
  • 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.
  • 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.
  • Maintain the GxP system inventory; conduct and document periodic system risk assessments to classify systems and determine appropriate validation scope and rigor.
  • 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.

Requirements

  • 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).
  • Proficiency authoring and reviewing CSA/CSV deliverables: VMPs, URSs, Risk Assessments, IQ/OQ/PQ protocols, traceability matrices, and validation summary reports.
  • Experience managing system change control and periodic review programs for validated GxP systems.
  • Ability to operate as both program owner and individual contributor in a lean, virtual organizational model

Nice to have

  • Experience with eQMS validation (e.g., Veeva Vault) and familiarity with Veeva's Qualified System approach and available supplier documentation.
  • 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.
  • Exposure to laboratory informatics systems (LIMS, ELN) and their GxP qualification requirements.
  • Experience in a virtual or lean biotech environment managing validation activities through external vendors and consultants.
  • Working knowledge of cybersecurity frameworks and their intersection with GxP system compliance (e.g., NIST, SOC 2).
  • Advanced degree in a relevant scientific, engineering, or regulatory discipline.
  • Fit with Nurix Culture and Values
  • You know the regulations deeply and apply them with judgment, designing validation approaches that are rigorous where it matters and efficient everywhere else.

Compensation

  • Senior Manager, CSA(Quality) - $170,538 - $193,493
  • Associate Director, CSA(Quality) - $190,269 - $216,360

Benefits

  • ensure test scripts are appropriately designed to demonstrate fitness for intended use.
  • Own and execute the periodic review program for validated GxP systems; assess continued fitness for intended use and compliance with current regulatory expectations.
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This listing is sourced directly from Nurix Therapeutics's careers page and normalized into a canonical job model.