Director, Quality Management Systems

Nurix•Brisbane, CA

2d•Onsite

About The 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

Requirements

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

Nice To Haves

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

Responsibilities

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.