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