Director, Quality Assurance

Director, Quality Assurance

Lead GMP quality assurance for Nurix's small molecule CMC programs and serve as the primary quality interface with our CDMO partners. You'll be accountable for the quality and timely supply of clinical materials and for inspection readiness, while building and mentoring the QA team as we advance through late-stage development toward commercialization.

Position Description

The Opportunity

Report to the Senior Vice President, Quality, in a high-visibility role with direct accountability across Quality, CMC, Regulatory Affairs, and external manufacturing partners; operate both strategically and hands-on in a dynamic clinical-stage environment

Provide strategic quality leadership for CMC development programs, ensuring GMP compliance with FDA, ex-US regulatory authorities, and ICH guidelines across drug substance and drug product development

Serve as the primary quality interface with CDMOs and contract laboratories, overseeing quality operations including review and approval of deviations, investigations, batch records, lot disposition, technical protocols and reports, methods, and specifications

Lead and develop a team of Quality Assurance professionals; set clear performance expectations, mentor, and build organizational capability to support pipeline advancement and commercialization readiness

Drive timely identification, investigation, and resolution of quality events and deviations, and oversee CAPA execution and effectiveness verification to prevent recurrence

Support the change control process, ensuring changes that affect manufacturing, testing, and regulatory filings are captured, and escalate issues with broad cross-functional impact

Support regulatory inspection readiness; serve as a quality representative during FDA, EMA, and other agency inspections and develop observation responses

Contribute to CMC sections of regulatory filings (INDs, NDAs/BLAs) in partnership with Regulatory Affairs, and partner with CMC and Regulatory Affairs to align quality deliverables with pipeline milestones and program timelines

Support implementation and optimization of the electronic quality management system (eQMS) platform and contribute to system improvement initiatives

Maintain current knowledge of evolving regulatory expectations and industry standards, and translate requirements into practical operational guidance for the organization

What You’ll Bring

Bachelor's degree in chemistry, pharmaceutical sciences, life sciences, or a related field

12+ years of progressive Quality Assurance experience in the pharmaceutical or biopharmaceutical industry, with experience in a formal leadership role

Deep technical expertise in GMP requirements for small molecule drug substances and drug products across clinical development stages

Demonstrated experience managing CDMO relationships and overseeing quality operations at contract manufacturing and laboratory organizations

Thorough knowledge of FDA regulations (21 CFR Parts 210/211), ICH guidelines (Q7, Q8, Q9, Q10, Q11), and EudraLex Volume 4 (GMP), and their practical application to CMC development

Proven track record managing quality events, deviations, CAPA programs, and change control in a clinical or commercial pharmaceutical setting

Experience supporting or leading regulatory agency inspections (FDA, EMA, or equivalent); experience as lead QA representative during pre-approval inspections preferred

Demonstrated ability to lead, develop, and motivate Quality Assurance teams in a fast-paced, ambiguous, clinical-stage environment

Excellent project management skills, with the ability to manage multiple high-priority deliverables simultaneously

Strong verbal and written communication skills; able to present complex quality and compliance topics clearly to diverse stakeholders, including executive leadership

Willingness to travel to CDMO and laboratory sites domestically and internationally, as needed

Preferred: experience in a clinical-stage biotech environment scaling quality operations through late-stage development and toward commercialization

Preferred: experience with electronic QMS platforms (e.g., Veeva Vault) and document management systems

Preferred: expertise in both development-phase and pre-commercial-phase quality assurance standards and expectations

Location: Onsite – Brisbane, CA

Salary Range: $228,100 - $252,000

The posted range applies to roles based in the San Francisco Bay Area and reflects local market conditions. Where an offer lands within that range depends on the candidate’s relevant experience, technical expertise, and how their background aligns with the role’s requirements.

Fit with Nurix Culture and Values

Strong team orientation; highly collaborative

Solutions and results-oriented focus

Hands-on approach; resourceful and open to diverse points of view

About Nurix Therapeutics

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.