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About the role
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. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- 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
- 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
- Support implementation and optimization of the electronic quality management system (eQMS) platform and contribute to system improvement initiatives
More about this role
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.
- 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...
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