Director, Quality Management Systems

Director, Quality Management Systems

Nurix Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation therapeutics. Leveraging our proprietary DELigase platform, we design small molecules that harness the body’s own protein disposal system to selectively eliminate disease-causing proteins. Our pipeline spans oncology and immune-mediated diseases, and our team is united by a commitment to scientific excellence and meaningful impact for patients.  We are a team of scientists, innovators, and problem-solvers committed to improving patient lives. We value integrity in everything we do — from the bench to the boardroom — and we foster an environment where every voice is heard and every contribution matters.

Position

The Director, Quality Management Systems is a newly created leadership role designed to address a critical need at Nurix Therapeutics. As the company advances its pipeline and scales its development operations, the need for a robust, efficient, and compliant Pharmaceutical Quality Management System (PQMS) infrastructure has never been greater. This role will own the strategy and execution of PQMS oversight across the organization, with a specific mandate to remediate and optimize the current Veeva Vault implementation, validate critical quality systems, and elevate the overall capabilities of the QMS team.

The Director will assess the current state of QMS operations, develop a prioritized improvement roadmap, and lead the upskilling of existing staff to meet late pivotal phase clinical operations and commercial industry standards. This is a high-visibility, high-impact role reporting directly to the Head of Quality, with cross-functional accountability across Quality, IT, CMC, and Regulatory Affairs

Responsibilites

• Own and lead the Quality Management Systems function, including document control, Training, Deviation/CAPA, and Change Control.
• Conduct a comprehensive assessment of the current PQMS and develop and execute a remediation plan to address inefficiencies, workflow gaps, and compliance deficiencies to include implementation of validated systems and the use of AI tools.
• Partner with IT to establish a Computer System Assurance (CSA) program for critical quality systems, ensuring compliance with 21 CFR Part 11, Annex 11, PIC/s, and applicable guidance.
• Partner with IT to define eQMS system requirements, manage system validation activities, and ensure appropriate data integrity controls are in place
• Define and implement PQMS performance metrics and KPIs; present trends and improvement initiatives to Quality leadership and cross-functional stakeholders
• Develop and execute a capability-building strategy for the QMS team, including structured onboarding, training programs, performance coaching, and clear competency standards
• Serve as the QMS subject matter expert during regulatory inspections and internal audits; support inspection readiness activities and manage observation responses
• Collaborate with Quality Operations, Regulatory Affairs, and Manufacturing to ensure QMS processes are integrated into day-to-day GMP operations and support pipeline milestones
• Drive standardization and continuous improvement of quality processes and procedures across the organization
• Manage and develop a team of QMS staff and contractors; provide mentorship, clear direction, and accountability for deliverables
• Maintain current knowledge of regulatory expectations for quality systems, data integrity, and GxP compliance; translate requirements into practical operational guidance
• Develop a regulatory intelligence solution for Nurix.

Qualifications 

• Bachelor’s degree in life sciences, engineering, information systems, or a related field; advanced degree preferred
• 10+ years of progressive quality systems experience in the pharmaceutical or biopharmaceutical industry; or 8+ years with a relevant advanced degree
• Demonstrated hands-on experience with Veeva Vault QMS, including system configuration, workflow design, and remediation or optimization initiatives
• Experience in computer system validation (CSV), 21 CFR Part 11, and GxP data integrity requirements
• Proven track record leading QMS infrastructure improvements in a clinical-stage or commercial biotech/pharma environment
• Knowledge of FDA and ICH GMP regulations (21 CFR Parts 210/211, Q8, Q9, Q10) and their practical application within PQMS frameworks
• Experience managing, developing, and upskilling quality teams; demonstrated ability to build organizational capability
• Exceptional communication and stakeholder management skills, including experience presenting to senior leadership and interacting with regulatory agency representatives
• Strategic thinker with strong operational execution skills; comfortable managing multiple high-priority initiatives simultaneously

Preferred Qualifications 

• Experience in a clinical-stage biotech company scaling QMS operations through pipeline advancement and potential commercialization
• Familiarity with small molecule and/or biologic drug development quality requirements
• Experience partnering with IT and validation teams on system implementation projects.
• Prior experience supporting FDA, EMA, or other regulatory agency inspections as QMS lead

Fit with Nurix Culture and Values 

• You lead with integrity and set the standard — you bring the same rigor and accountability to quality systems that our scientists bring to the bench
• You are a builder who thrives in ambiguity, energized by the opportunity to shape something meaningful from the ground up in a high-growth environment
• You invest in people — you know that sustainable quality outcomes depend on capable, engaged teams, and you take developing others as seriously as you take system compliance

Salary Range: $211,698 - $243,384 plus bonus and equity 

Location:  Brisbane, CA – Onsite

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