Full-Time

Associate Director

Computer Systems Assurance, Quality

Updated on 9/3/2026

Nurix Therapeutics

Nurix Therapeutics

201-500 employees

Drug discovery targeting ubiquitin E3 ligases

Compensation Overview

$190k - $217k/yr

Brisbane, CA, USA

In Person

On-site work in Brisbane, California is required.

Bachelor's

Category
Biology & Biotech (1)
Required Skills
Cybersecurity
SOC 2

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Requirements
  • A bachelor's degree in computer science, information systems, life sciences, pharmaceutical sciences, or a related field.
  • Seven to ten or more years of progressive experience in computer systems validation and/or computer systems assurance in a GxP-regulated pharmaceutical, biopharmaceutical, or biotechnology environment.
  • Expertise in current computerized-systems regulations and guidance, including FDA 21 CFR Part 11, EU Annex 11, FDA computer software assurance guidance from 2022, and GAMP 5, second edition.
  • Hands-on experience validating software-as-a-service and cloud-hosted GxP platforms, including understanding vendor-managed environments and shared-responsibility models.
  • Proficiency authoring and reviewing CSA/CSV deliverables, including Validation Master Plans, User Requirements Specifications, risk assessments, IQ/OQ/PQ protocols, traceability matrices, and validation summary reports.
  • Strong working knowledge of data-integrity principles, including 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 and manage validation activities without a large internal support team.
  • Ability to translate complex technical and regulatory requirements into practical guidance for diverse stakeholders.
  • Ability to manage multiple concurrent programs and priorities in a fast-paced environment.
  • Strong organizational skills and attention to detail.
Responsibilities
  • Own and maintain the Computer Systems Assurance policy framework, standard operating procedures, and risk-based validation strategy.
  • Define and implement a fit-for-purpose, risk-tiered approach to qualification of software-as-a-service and cloud-hosted GxP applications.
  • Maintain the GxP system inventory and conduct and document periodic system risk assessments to classify systems and determine validation scope and rigor.
  • Establish and maintain vendor-assessment processes, including review of vendor SOC 2 reports, quality agreements, and audit strategies for software-as-a-service providers.
  • Drive continuous improvement through benchmarking, regulatory intelligence, and adoption of industry best practices.
  • Lead and execute validation activities for GxP software-as-a-service platforms, including electronic quality management systems, electronic document management, clinical data management, regulatory information management, and laboratory information systems.
  • Author and review validation documentation, including Validation Master Plans, User Requirements Specifications, risk assessments, vendor assessments, validation protocols, traceability matrices, and validation summary reports.
  • Manage validation activities for system implementations, major configuration changes, upgrades, and periodic re-validation reviews.
  • Coordinate validation testing with cross-functional stakeholders and ensure test scripts demonstrate fitness for intended use.
  • Review and approve validation deliverables prepared by internal teams, vendors, or external validation consultants.
  • Serve as the internal subject-matter expert for 21 CFR Part 11 and EU Annex 11 requirements and assess systems for compliance.
  • Partner with IT and system owners to ensure electronic-record and electronic-signature controls are implemented and documented in GxP systems.
  • Support data-integrity assessments and remediation initiatives using ALCOA+ principles.
  • Manage the computerized-systems change-control process and evaluate proposed changes for validation impact.
  • Own and execute the periodic-review program for validated GxP systems.
  • Maintain validation-status documentation and ensure validation files remain audit-ready.
  • Support regulatory-inspection preparation and serve as the CSA subject-matter expert during FDA, EMA, and other health-authority inspections.
  • Contribute to regulatory submissions and respond to agency questions concerning computerized systems and data integrity.
  • Monitor evolving regulatory guidance and industry standards and adapt the CSA program accordingly.
  • Serve as the primary point of contact and internal consultant for 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.
  • Partner with IT and vendor project teams to embed validation requirements in system selection and implementation processes.
Desired Qualifications
  • Experience with electronic quality management system validation, such as Veeva Vault, and familiarity with Veeva's Qualified System approach and supplier documentation.
  • Familiarity with clinical development platforms such as electronic data capture, regulatory information management, or clinical trial management systems in a validated context.
  • Experience supporting FDA, EMA, or equivalent health-authority inspections as a CSA subject-matter expert.
  • Exposure to laboratory informatics systems, including laboratory information management systems and electronic laboratory notebooks, and their GxP qualification requirements.
  • Experience managing validation activities through external vendors and consultants in a virtual or lean biotechnology environment.
  • Working knowledge of cybersecurity frameworks and their intersection with GxP system compliance, including NIST and SOC 2.
  • An advanced degree in a relevant scientific, engineering, or regulatory discipline.

Nurix Therapeutics develops drugs that use the body's own protein-degradation system to treat diseases. Its core approach is to control ubiquitin E3 ligases, enzymes that tag unwanted proteins for breakdown in cells. By modulating these ligases, Nurix aims to create therapeutics, especially small-molecule immuno-oncology agents, that can selectively remove disease-related proteins in cancer and other serious conditions. The company operates by discovering and developing drug candidates and earning revenue through partnerships, licensing, and potential future sales of its medicines. Unlike many biotech firms that target single proteins, Nurix focuses on the protein-degradation pathway to influence multiple disease processes through carefully designed molecules. The goal is to bring new cancer treatments and other therapies to patients by advancing its degrader-based drugs through research, collaboration, and development toward commercial use.

Company Size

201-500

Company Stage

IPO

Headquarters

San Francisco, California

Founded

2012

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Simplify Jobs

Simplify's Take

What believers are saying

  • Roche deal delivers $700 million upfront and up to $2.3 billion total payments.
  • June 2026 clinical data strengthened bexobrutideg across BTK-resistant and CNS-involved CLL patients.
  • Management expects Phase 3 initiation in summer 2026 and possible 2030 commercialization.

What critics are saying

  • May 31, 2026 cash was $443.5 million before Roche's $700 million payment closes.
  • Bexobrutideg faces pirtobrutinib in the planned 2026 Phase 3 CLL head-to-head trial.
  • If bexobrutideg disappoints, Nurix's valuation collapses because Sanofi revenue already fell sharply.

What makes Nurix Therapeutics unique

  • Roche and Nurix co-develop bexobrutideg after July 21, 2026 HSR clearance.
  • June 11, 2026 EHA data showed 83% ORR and 22.1-month median PFS in CLL.
  • Nurix owns a broad degrader platform spanning BTK, CBL-B, AURKA, and mutant BRAF.

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Benefits

Company Equity

Growth & Insights and Company News

Headcount

6 month growth

-3%

1 year growth

-3%

2 year growth

-2%
Yahoo Finance
Aug 20th, 2026
Nurix Therapeutics appoints Wes Burwell as chief human resources officer

Nurix Therapeutics, a clinical-stage biopharmaceutical company developing targeted protein degradation medicines, has appointed Wes Burwell as chief human resources officer. Burwell will join the company's executive management team and lead its human resources organisation as it advances its late-stage clinical pipeline and prepares for commercialisation. Burwell brings over 20 years of human resources leadership experience in life sciences. He previously served as vice president of human resources at Bolt Biotherapeutics and held senior HR roles at Global Blood Therapeutics, where he supported the company's growth from early clinical development through successful commercialisation of its first therapy. Arthur T. Sands, president and chief executive officer of Nurix, said Burwell's experience in scaling organisations and fostering high-performing cultures makes him an exceptional addition as the company prepares for its next growth phase.

cash.ch
Jun 8th, 2026
Roche enters into billion-dollar deal with Nurix for blood cancer drug Bexobrutideg.

Roche enters into billion-dollar deal with Nurix for blood cancer drug Bexobrutideg. Roche and the US biotech company Nurix Therapeutics want to jointly develop and market the drug Bexobrutideg. 07.06.2026 23:01 The drug is intended to treat blood cancer (BTK), certain skin diseases and multiple sclerosis, as the pharmaceutical company Roche announced on Monday. Bexobrutideg belongs to a new class of drugs that specifically break down the protein BTK - an important switch in the immune system - instead of merely blocking it. This is intended to overcome resistance that occurs with current therapies. Nurix receives an upfront payment of 700 million US dollars and possible further payments of up to 2.3 billion dollars. The two companies share the development costs, with Roche covering 60 percent. In the US, both companies will market the drug together; outside the US, Roche will handle sales alone. A pivotal phase III study for the treatment of blood cancer - specifically chronic lymphocytic leukemia - is expected to start in summer 2026. As Roche further writes, blood cancer-targeting agents represent a leading class within the growing markets for non-Hodgkin lymphoma (NHL) and CLL. The overall market is forecast to reach a volume of 41 billion dollars by 2031, with BTK inhibitors (BTKi) remaining the highest-revenue class at about 19 billion dollars. 'This growth is particularly evident in the CLL sector, which is projected to increase from 12 billion US dollars in 2024 to 16 billion US dollars by 2035,' the statement continues.

Yahoo Finance
Jun 8th, 2026
Nurix bags $700M upfront from Roche in BTK degrader bexobrutideg collaboration worth up to $2.3B

Nurix Therapeutics has announced a global collaboration with Roche to co-develop and co-commercialise bexobrutideg, a BTK degrader targeting malignant hematology, immunology and neurology. Nurix will receive an upfront payment of $700 million and is eligible for development, regulatory and sales milestones totalling up to $2.3 billion. The partnership combines Nurix's protein degradation expertise with Roche's B-cell therapy portfolio and global infrastructure. The clinical development plan builds on the ongoing pivotal programme in chronic lymphocytic leukaemia and includes combination regimens across B-cell malignancies, plus Phase 2 trials in multiple sclerosis and chronic spontaneous urticaria. Profits and losses will be shared equally in the United States, with Nurix receiving royalties on sales outside the US.

GlobeNewswire
Jun 8th, 2026
Roche announces global collaboration with Nurix Therapeutics to co-develop and co-commercialise potential best-in-class BTK degrader bexobrutideg across malignant haematology, immunology and neurology.

Roche announces global collaboration with Nurix Therapeutics to co-develop and co-commercialise potential best-in-class BTK degrader bexobrutideg across malignant haematology, immunology and neurology. * Agreement offers potential best-in-class targeted protein degrader therapy option for people living with B-cell malignancies * Collaboration adds to Roche's oncology pipeline and offers potential indications in immunology (chronic spontaneous urticaria) and neurology (multiple sclerosis) * Bexobrutideg utilises a novel approach to eliminate the Bruton's Tyrosine Kinase (BTK) protein, potentially overcoming existing resistance mechanisms found with current standard-of-care BTK inhibitors Basel, 08 June 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that it has entered into an exclusive licensing and collaboration agreement with Nurix Therapeutics, Inc. (Nasdaq: NRIX). Under the terms of this agreement, the two companies will collaborate to co-develop and co-commercialise bexobrutideg (NX-5948), Nurix's investigational Bruton's Tyrosine Kinase (BTK) degrader. The collaboration encompasses a clinical development plan spanning B-cell malignancies, immunology and neurology. The addition of bexobrutideg complements Roche's existing strengths in haematology and provides a cross-therapeutic opportunity to extend the pipeline's reach in immunology and neurology. Patients with B-cell-driven malignancies continue to face significant unmet need despite advances with BTK inhibitors and other therapies. In haematology, many patients with CLL ultimately experience disease progression due to acquired resistance mutations, incomplete pathway suppression, or intolerance that limits long-term use, and treatment options remain limited once patients relapse. BTK-targeting assets represent a leading class within the expanding non-Hodgkin lymphoma (NHL) and CLL markets. The combined market is projected to reach $41 billion by 2031, with BTK inhibitors (BTKi) expected to remain the sales-leading class at approximately $19 billion.[1] This growth is particularly evident in the CLL sector, which is forecast to increase from $12 billion in 2024 to $16 billion by 2035.[2] Bexobrutideg, an oral targeted BTK degrader, is planned for Phase 3 clinical trial initiation in summer 2026 for the second-line treatment of CLL. Available clinical data suggests it has the potential to become a best-in-class treatment option with higher efficacy and more favorable tolerability than established therapies. In addition, it offers the potential to overcome resistance mechanisms found in current standard-of-care BTK inhibitors. This collaboration creates a unique opportunity to leverage Roche's industry-leading malignant haematology portfolio. Levi Garraway, Roche Chief Medical Officer and Head of Global Product Development: "At Roche, our goal is to create new possibilities for patients with challenging diseases. We believe bexobrutideg could represent a major leap forward in the fight against complex blood cancers and other diseases. We are proud to join forces with Nurix to accelerate these potential breakthroughs." Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix Therapeutics: "We believe Roche is the ideal partner to help translate the promise of targeted protein degradation into meaningful impact for patients worldwide. As a single agent, bexobrutideg has shown highly promising results in B cell malignancy clinical trials to date and we can now rapidly expand our Phase 3 program enhanced by Roche's global reach. We are also excited to explore combination regimens utilising selected agents from Roche's portfolio of successful B-cell malignancy drugs. In addition, collaborating with Roche uniquely enables our ability to extend the cross-therapeutic opportunity of bexobrutideg in immunology and neurology." While BTK is a proven target in B-cell malignancies, it is also a critical signaling node driving various conditions in immunology and neurology. Because of bexobrutideg's ability to eliminate both the kinase and scaffolding functions of BTK across immune cell types it has the potential for improved efficacy and durability in these diseases. Terms of the agreement Under the terms of the agreement, Nurix will receive an upfront cash payment of USD 700 million and is eligible to receive development, regulatory and sales milestones for a potential total deal value of up to USD 2.3 billion. Development costs will be shared 40% by Nurix and 60% by Roche. The parties will equally split the profits and losses from U.S. commercialisation. Nurix and Roche will co-commercialise bexobrutideg in the United States across all indications. Outside of the United States, Roche will be responsible for commercialisation, with Nurix receiving royalties ranging from the low- to high-teens. The transaction is subject to customary closing conditions, including the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. The parties currently expect the transaction to close in the third quarter of 2026. About bexobrutideg Bexobrutideg (NX-5948) is an investigational, orally bioavailable, brain-penetrant BTK degrader for the treatment of relapsed or refractory B-cell malignancies and potentially diseases in immunology and neurology. BTK is a central signaling node controlling B cell growth, development and immunologic activity. Unlike conventional BTK inhibitors, which block BTK kinase activity, bexobrutideg harnesses the body's natural protein disposal system. Bexobrutideg selectively eliminates BTK protein from cells, removing both its kinase activity and scaffolding function, potentially overcoming existing treatment-emergent resistance mutations and unlocking new therapeutic potential of targeting BTK. About malignant haematology B-cell malignancies, including chronic lymphocytic leukaemia (CLL), represent a significant health challenge where recent scientific advances can help meet high unmet medical needs. CLL is a slow-growing cancer in the blood and bone marrow and is one of the most common forms of leukemia in adults. While outcomes have improved in recent years, patients often face long treatment durations and ongoing disease management challenges. Although signs of CLL may disappear for a while after initial treatment, many people require additional treatment due to the return of cancerous cells. About CSU and MS CSU is a debilitating, long-term, immune mediated skin condition characterized by recurring, itchy hives. MS is a chronic disease affecting nearly 3 million people worldwide. It occurs when the immune system attacks the protective covering of nerves in the brain and spinal cord, disrupting signals throughout the body and causing movement and neurological challenges. About Roche Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions. Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them. Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market. All trademarks used or mentioned in this release are protected by law. References [1] Clarivate, NHL/CLL Disease Landscape and Forecast, 2024. [2] DRG (Decision Resources Group) & Datamonitor Healthcare, CLL Market Analysis, 2025. Roche Global Media Relations Phone: +41 61 688 8888 / e-mail: [email protected] | Hans Trees, PhD Phone: +41 79 407 72 58 | Lorena Corfas Phone: +41 79 568 24 95 | | Simon Goldsborough Phone: +44 797 32 72 915 | Karsten Kleine Phone: +41 79 461 86 83 | | Kirti Pandey Phone: +41 79 398 38 53 | Yvette Petillon Phone: +41 79 961 92 50 | | Dr Rebekka Schnell Phone: +41 79 205 27 03 | Irène Stephan Phone: +41 79 377 83 75 | Roche Investor Relations | Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: [email protected] | Dr Sabine Borngräber Phone: +41 61 68-88027 e-mail: [email protected] | | Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: [email protected] | / | Investor Relations North America | Loren Kalm Phone: +1 650 225 3217 e-mail: [email protected] | / |

Nurix Therapeutics, Inc.
May 12th, 2026
Press releases.

Press releases. Nurix Therapeutics announces bexobrutideg oral presentation at the 2026 European Hematology Association Congress. May 12, 2026 BRISBANE, Calif., May 12, 2026 (GLOBE NEWSWIRE) - Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, today announced that an abstract highlighting updated efficacy and safety data from the ongoing Phase 1a/b trial of BTK degrader bexobrutideg (NX-5948) in patients with chronic lymphocytic leukemia (CLL) across lines of therapy has been accepted for oral presentation at the 31st Congress of the European Hematology Association (EHA2026), taking place June 11-14, 2026, in Stockholm, Sweden. Oral Presentation Details: Title: Updated efficacy and safety data from an ongoing phase 1a/b trial of the BTK degrader bexobrutideg (NX-5948) in patients with CLL across lines of therapy Presenter: Tahla Munir, MBChB, Ph.D. Session title: s449 Novel therapies in relapsed/refractory CLL Session date and time: June 14, 2026, 11:00 - 12:15 CEST Session Room: A10-11 Hall Abstract ID: S150 About Bexobrutideg (NX-5948) Bexobrutideg is an investigational, orally bioavailable, brain penetrant, highly selective small molecule degrader of Bruton's tyrosine kinase (BTK) currently being evaluated in the DAYBreak CLL-201 clinical trial (NCT07221500), a pivotal single-arm Phase 2 study of bexobrutideg in patients with relapsed or refractory CLL. Nurix also continues enrollment in the NX-5948-301 Phase 1a/1b clinical trial (NCT05131022) of bexobrutideg in patients with relapsed or refractory B cell malignancies. Additional information on the ongoing clinical trials can be accessed at clinicaltrials.gov. About Nurix Therapeutics, Inc. 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 autoimmune diseases. Nurix's wholly owned, clinical stage pipeline includes degraders of Bruton's tyrosine kinase (BTK), a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene B (CBL-B), an E3 ligase that regulates activation of multiple immune cell types including T cells and NK cells. Nurix also is advancing multiple potentially first-in-class or best-in-class degraders and degrader antibody conjugates (DACs) in its preclinical pipeline. Nurix's partnered drug discovery pipeline consists of a preclinical stage degrader of STAT6, SAR448272/NX-3911, in collaboration with Sanofi, a clinical stage degrader of IRAK4, GS6791, in collaboration with Gilead, as well as multiple additional programs under collaboration agreements with Gilead Sciences, Inc., Sanofi S.A. and Pfizer Inc., within which Nurix retains certain options for co-development, co-commercialization and profit sharing in the United States for multiple drug candidates. Powered by an AI-integrated discovery engine capable of tackling virtually 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. Nurix is headquartered in Brisbane, California. For additional information visit http://www.nurixtx.com.