Overview
Nurix Therapeutics is a clinical‐stage biopharmaceutical company focusing on the discovery, development, and commercialization of targeted protein degradation medicines. Powered by an AI‐integrated discovery engine and deep ligase expertise, the company aims to establish degrader‐based treatments at the forefront of patient care.
Position
The Senior Manager / Associate Director, Computer Systems Assurance (CSA) is a key technical and operational leader within the Nurix Quality Systems organization. The role owns and advances Nurix's computer systems assurance program, working within a lean virtual environment that relies on SaaS and cloud‐hosted platforms to support GxP‐regulated activities.
Reporting to the Vice President / Senior Director, Quality Systems, the candidate will design and maintain a risk‐based CSA framework aligned with FDA 2022 guidance, GAMP 5, 21 CFR Part 11, and Annex 11, translating regulatory requirements into practical validation approaches for modern, agile biotech operations.
Responsibilities
CSA Program Ownership and Strategy
* Own and maintain Nurix's Computer Systems Assurance policy framework, SOPs, and risk‐based validation strategy in line with FDA CSA guidance, GAMP 5, 21 CFR Part 11, EU Annex 11, and ICH guidelines.
* Define and implement a fit‐for‐purpose, risk‐tiered approach to system qualification for SaaS and cloud‐hosted GxP applications.
* Maintain the GxP system inventory; conduct and document periodic system risk assessments to classify systems and determine appropriate validation scope.
* Establish and maintain processes for vendor assessment, including review of vendor SOC 2 reports, quality agreements, and audit strategies.
* 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 such as eQMS (e.g., Veeva Vault), electronic document management, clinical data management, regulatory information management, and laboratory information systems.
* Author and review validation documentation – VMPs, URSs, risk assessments, vendor assessments, validation protocols (IQ/OQ/PQ), traceability matrices, and summary reports.
* Manage validation activities for system implementations, major configuration changes, upgrades, and periodic re‐validation, scoping effort to system risk and change impact.
* Coordinate validation testing with cross‐functional stakeholders to design test scripts that demonstrate fitness for intended use.
* Review and approve validation deliverables prepared by internal teams, vendors, or external 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, assessing systems for compliance and providing guidance.
* 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 assessments and remediation initiatives, applying ALCOA+ principles to guide compliant system design.
Change Management and Periodic Review
* Manage the computerized systems change control process, evaluating proposed changes for validation impact and establishing assessment, testing, and documentation requirements.
* Own and execute the periodic review program for validated GxP systems, assessing continued fitness for intended use and compliance with current regulatory expectations.
* Maintain validation status documentation and ensure validation files are audit‐ready at all times.
Inspection Readiness and Regulatory Support
* Support preparation for regulatory inspections; serve as the CSA expert during FDA, EMA, and other Health Authority inspections, ensuring validation documentation is complete, current, and accessible.
* Contribute to regulatory submissions and respond to agency questions related to computerized systems and data integrity.
* Monitor evolving regulatory guidance and industry standards, proactively adapting Nurix's program to reflect current expectations.
Cross‐Functional Partnership and Training
* Serve as the primary point of contact and internal consultant for all GxP system owners across Quality, IT, Regulatory Affairs, CMC, and Clinical Operations.
* Develop and deliver CSA training for system owners, end users, and stakeholders to build organizational capability.
* Partner with IT and vendor project teams to embed validation requirements early in system selection and implementation processes.
Required 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 assurance within a GxP‐regulated pharmaceutical, biopharmaceutical, or biotechnology environment.
* Demonstrated expertise in FDA 21 CFR Part 11, EU Annex 11, FDA CSA guidance (2022), and GAMP 5.
* 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 knowledge of data‐integrity principles (ALCOA+) applied to electronic records management and GxP system design.
* 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 organization.
* 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 in a fast‐paced environment.
Preferred Qualifications
* Experience with eQMS validation (e.g., Veeva Vault) and familiarity with Veeva's Qualified System approach.
* Familiarity with clinical development platforms such as EDC, RIM, or CTMS in a validated context.
* Experience supporting FDA, EMA, or equivalent Health Authority inspections as a CSA subject‐matter expert.
* 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 (e.g., NIST, SOC 2) and their intersection with GxP compliance.
* 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 robust yet efficient validation approaches.
* You are comfortable acting as the go‐to expert, driving the CSA program forward proactively and owning outcomes.
* You build trusted relationships across Quality, IT, and business units, recognizing that a well‐designed compliant systems environment enables Nurix's mission to develop important medicines for patients.
Location: Brisbane, CA – Onsite
Salary Ranges:
Senior Manager, CSA (Quality) – $170,538 – $193,493
Associate Director, CSA (Quality) – $190,269 – $216,360
Nurix Therapeutics, Inc. is committed to protecting and respecting your privacy and personal information. By applying for a position at Nurix, you agree to our collection and use of personal information as described in our Privacy Policy (https://www.nurixtx.com/privacy-policy/).
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