Director, Quality Assurance
About The Position
The Director, Quality Assurance will lead GMP quality assurance for Nurix’s small molecule CMC programs and serve as the primary quality interface with CDMO partners. The role is accountable for the quality and timely supply of clinical materials and inspection readiness, while building and mentoring the QA team as the company advances through late-stage development toward commercialization. Reporting to the Senior Vice President, Quality, this high-visibility position has direct accountability across Quality, CMC, Regulatory Affairs, and external manufacturing partners. It combines strategic leadership with hands-on work in a dynamic clinical-stage environment. The Director provides quality leadership for CMC development programs; oversees quality operations at CDMOs and contract laboratories; leads quality event, deviation, CAPA, and change-control activities; and supports regulatory inspections and CMC filings. The role also contributes to implementation and optimization of the eQMS and translates changing regulatory expectations into practical guidance. Nurix Therapeutics is a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing targeted protein degradation medicines for cancer and inflammatory diseases.
Requirements
- 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, including 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.
- Demonstrated ability to lead, develop, and motivate Quality Assurance teams in a fast-paced, ambiguous, clinical-stage environment.
- Excellent project management skills and ability to manage multiple high-priority deliverables simultaneously.
- Strong verbal and written communication skills, including the ability to clearly present complex quality and compliance topics to diverse stakeholders and executive leadership.
- Willingness to travel domestically and internationally to CDMO and laboratory sites as needed.
Nice To Haves
- Experience supporting or leading regulatory agency inspections (FDA, EMA, or equivalent); experience as lead QA representative during pre-approval inspections is preferred.
- Experience in a clinical-stage biotech environment scaling quality operations through late-stage development and toward commercialization.
- Experience with electronic QMS platforms such as Veeva Vault and document management systems.
- Expertise in both development-phase and pre-commercial-phase quality assurance standards and expectations.
Responsibilities
- Provide strategic quality leadership for CMC development programs and ensure 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 review and approval of deviations, investigations, batch records, lot disposition, technical protocols and reports, methods, and specifications.
- Lead and develop Quality Assurance professionals, set performance expectations, mentor team members, and build organizational capability for pipeline advancement and commercialization readiness.
- Drive timely identification, investigation, and resolution of quality events and deviations; oversee CAPA execution and effectiveness verification.
- Support change control so changes affecting manufacturing, testing, and regulatory filings are captured, and escalate issues with broad cross-functional impact.
- Support regulatory inspection readiness, represent Quality during FDA, EMA, and other agency inspections, and develop responses to observations.
- Contribute to CMC sections of IND and NDA/BLA filings with Regulatory Affairs, and align quality deliverables with CMC and Regulatory Affairs milestones and program timelines.
- Support implementation and optimization of the electronic quality management system and contribute to system improvement initiatives.
- Maintain knowledge of evolving regulatory expectations and industry standards and translate requirements into practical operational guidance.
- Travel to CDMO and laboratory sites domestically and internationally as needed.
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What This Job Offers
Job Type
Full-time
Career Level
Director
