---
title: 'Associate Director, Computer Systems Assurance (Quality) at Nurix'
canonical: 'https://feeny.ai/job/associate-director-computer-systems-assurance-quality-nurix-brisbane-yp5d0v301yxc'
type: 'job'
last_seen: '2026-09-09'
---

# Associate Director, Computer Systems Assurance (Quality) at Nurix

- **Company:** Nurix
- **Location:** Brisbane, CA
- **Posted:** 2026-05-05
- **Last confirmed live:** 2026-09-09
- **Apply:** https://job-boards.greenhouse.io/nurix/jobs/8535914002

## Job description

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 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 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.

## 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 assessments and remediation initiatives; apply ALCOA+ principles to guide compliant system design and use.

Change Management and Periodic Review

- Manage the computerized systems change control process; evaluate proposed changes for validation impact and establish appropriate assessment, testing, and documentation requirements prior to implementation.
- Own and execute the periodic review program for validated GxP systems; assess 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 agency inspections; serve as the CSA subject matter expert during FDA, EMA, and other Health Authority inspections and ensure validation documentation is complete, current, and accessible.
- Contribute to relevant sections of regulatory submissions and respond to agency questions related to computerized systems and data integrity.
- Monitor evolving regulatory guidance and industry standards related to CSA, CSV, data integrity, and cloud-based systems; proactively adapt 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 other stakeholders to build organizational capability and awareness.
- 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 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.
- 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; 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.

## Preferred Qualifications

- 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.
- 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 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. You bring expertise with pragmatism —
- You are comfortable as the go-to expert, driving the CSA program forward proactively rather than waiting for direction, and you take accountability for outcomes. You own the program —
- You build trusted relationships across Quality, IT, and the business, and you understand that a well-designed, compliant systems environment is an enabler of Nurix's mission to develop important medicines for patients. You partner with purpose —

Location: Brisbane, CA - Onsite

Salary Ranges:  190K - 217K

## About Nurix

## Company Overview
- **One-liner**: Nurix Therapeutics is a clinical-stage biopharmaceutical company pioneering targeted protein degradation medicines to outmatch disease by harnessing the cell’s natural protein disposal system.
- **Entity Type**: Public (NASDAQ: NRIX)
- **Headquarters**: San Francisco, California, USA
- **Founded**: 2009
- **Founders**: Not publicly listed as individual founders; the company was spun out from research at UC Berkeley and UC San Francisco.

## Core Business
- **Primary industry**: Biopharmaceuticals / Targeted Protein Degradation
- **Target customers**: B2B (pharma partners) and B2C (patients via clinical trials and eventual commercial therapies); enterprise-level partnerships with major pharma.
- **Mission or purpose statement**: "Writing medicine’s next chapter using targeted protein degradation as a new script to outmatch disease." [nurixtx.com](https://www.nurixtx.com/)

## Products & Services
- **Bexobrutideg (NX-5948)**: A potential best-in-class BTK degrader in Phase 1b/2 clinical trials for relapsed/refractory CLL/SLL and chronic spontaneous urticaria. Co-developed and co-commercialized with Roche under a global collaboration announced June 2026. [nurixtx.com](https://www.nurixtx.com/)
- **NX-2127**: A BTK degrader in clinical development for B-cell malignancies.
- **CBL-B Inhibitor (NX-1607)**: An E3 ligase inhibitor designed to activate T cells for immuno-oncology, in Phase 1 clinical trials.
- **IRAK4 Degrader**: A partnered program with Gilead in Phase 1 for inflammatory diseases.
- **STAT6 Degrader**: A partnered program with Sanofi in IND-enabling studies.
- **DEL-AI Discovery Engine**: A proprietary, fully AI-integrated platform combining DNA-encoded libraries (DEL), automated chemistry, and machine learning to design and optimize targeted protein degraders and degrader-antibody conjugates (DACs).

## Market Standing
- **Valuation/Market Cap**: Not publicly available in the provided search results; as a public company (NRIX), market cap fluctuates daily. Check financial platforms for the latest figure.
- **Key Metric**: Annual Revenue (public) — Not publicly available in the provided search results; as a clinical-stage biotech, revenue is typically minimal or pre-revenue. Total funding raised prior to IPO is not detailed in the provided results.
- **Notable Investors/Partners**: Roche (global co-development and co-commercialization collaboration for bexobrutideg, announced June 2026), Gilead (partnered IRAK4 degrader program), Sanofi (partnered STAT6 degrader program).
- **Growth Signals**: Announced a landmark global collaboration with Roche in June 2026 to co-develop and co-commercialize bexobrutideg across malignant hematology, immunology, and neurology. Presented positive Phase 1a/b data for bexobrutideg in CLL/SLL and chronic spontaneous urticaria in 2026. Multiple partnered and wholly owned pipeline programs advancing through clinical and preclinical stages.

## Competitive Advantages
- **Proprietary DEL-AI Discovery Engine**: A fully AI-integrated platform combining DNA-encoded libraries, automated chemistry, and machine learning to design degraders against any protein class, providing a significant speed and innovation advantage. [nurixtx.com](https://www.nurixtx.com/)
- **Unparalleled Ligase Expertise**: Deep understanding of E3 ligase biochemistry and biology, a critical and complex component of the protein degradation mechanism, giving them a unique moat.
- **Multi-Modal Pipeline**: Developing both small molecule degraders and Degrader-Antibody Conjugates (DACs), expanding the therapeutic reach and creating multiple shots on goal.
- **Strong Partnership Network**: Collaborations with top-tier pharma (Roche, Gilead, Sanofi) validate their platform and provide non-dilutive funding and shared risk.

## Strategic Focus
- **Clinical Advancement**: Driving lead asset bexobrutideg through pivotal trials in CLL/SLL and expanding into immunology (chronic spontaneous urticaria) and neurology.
- **Platform Expansion**: Leveraging the DEL-AI engine to develop Degrader-Antibody Conjugates (DACs) for enhanced cell specificity and safety.
- **Pipeline Breadth**: Advancing a multi-modal pipeline across oncology, immunology, and neurology, both wholly owned and through strategic partnerships.
- **Partnership Leverage**: Deepening collaborations with Roche, Gilead, and Sanofi to co-develop and co-commercialize programs, reducing risk and accelerating timelines.

## Why Work Here
- **Culture**: Mission-focused, values-based, and spirited culture emphasizing "breakthrough innovation," "leadership," "accountability," and "zealousness." Employees are encouraged to "think big and act bold." [nurixtx.com](https://www.nurixtx.com/work-at-nurix/)
- **Work with Industry Leaders**: The team includes scientific innovators who built the protein degradation field, seasoned executives with biotech scaling expertise, and leading clinicians. [nurixtx.com](https://www.nurixtx.com/work-at-nurix/)
- **Growth & Impact**: Employees can "wear many hats" and gain broad exposure in a lean, virtual drug developer environment. The company emphasizes career growth and opportunity-rich experiences.
- **Work Policy**: Onsite in Brisbane, CA (San Francisco Bay Area) for most roles, as indicated by job postings. [nurixtx.com](https://www.nurixtx.com/explore-jobs/)
- **Benefits**: Comprehensive health and welfare plans, enhanced parental leave, wellness reimbursement, 401(k) employer match, and a highly collaborative culture. [nurixtx.com](https://www.nurixtx.com/work-at-nurix/)
- **Engineering/Science Culture**: Described as "mission-focused, values-based, and spirited," with a focus on "intellectual and technical ingenuity" and "intelligent risk-taking." The company is a "virtual drug developer" with a lean internal infrastructure, relying on SaaS and cloud platforms. [nurixtx.com](https://www.nurixtx.com/explore-jobs/)

## Sources
1. [nurixtx.com](https://www.nurixtx.com/)
2. [nurixtx.com](https://www.nurixtx.com/work-at-nurix/)
3. [nurixtx.com](https://www.nurixtx.com/explore-jobs/)
4. [nurixtx.com](https://www.nurixtx.com/our-story/)

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