Senior Director, Quality Assurance

Nurix•Brisbane, CA

2d•Onsite

About The Position

Senior Director, Quality Assurance Nurix Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation therapeutics. Leveraging our proprietary DELigase platform, we design small molecules that harness the body's own protein disposal system to selectively eliminate disease-causing proteins. Our pipeline spans oncology and immune-mediated diseases, and our team is united by a commitment to scientific excellence and meaningful impact for patients.We are a team of scientists, innovators, and problem-solvers committed to improving patient lives. We value integrity in everything we do — from the bench to the boardroom — and we foster an environment where every voice is heard and every contribution matters. Position The Senior Director, Quality Assurance is a leadership role within the Nurix Quality organization, responsible for providing strategic and operational oversight of GMP/GLP quality assurance activities supporting small molecule CMC development. This leader will serve as the primary quality interface with external contract development and manufacturing organizations (CDMOs), ensuring the quality, compliance, and timely supply of clinical materials across Nurix’s pipeline programs. Reporting to the Senior Vice President, Quality, the Senior Director will apply sound independent judgment to drive timely identification, investigation, and resolution of quality events, while building a culture of continuous improvement and cross-functional collaboration. This individual will be accountable for regulatory inspection readiness, quality oversight of external manufacturing and laboratory partners, and for contributing to the evolution of Nurix’s quality systems as the company advances through late-stage clinical development and toward commercialization. This is a high-visibility role with direct accountability across Quality, CMC, Regulatory Affairs, and external manufacturing partners. The Senior Director will lead and mentor a team of Quality Assurance professionals and will be expected to operate both strategically and hands-on as needed in a dynamic, early to late clinical-stage environment.

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, with experience in 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) and ICH guidelines (Q7, Q8, Q9, Q10, Q11), and EudraLex - Volume 4 - Good Manufacturing Practice (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.

Nice To Haves

Experience in a clinical-stage biotech environment scaling quality operations through late-stage development and toward commercialization.
Experience with electronic QMS platforms (e.g., Veeva Vault) and document management systems.
Expertise in both development-phase and pre-commercial-phase quality assurance standards and expectations.
Fit with Nurix Culture and Values
You lead with integrity and set the standard — you bring the same rigor and accountability to quality systems that our scientists bring to the bench
You are a builder who thrives in ambiguity, energized by the opportunity to shape something meaningful from the ground up in a high-growth environment
You invest in people — you know that sustainable quality outcomes depend on capable, engaged teams, and you take developing others as seriously as you take system compliance

Responsibilities

Provide strategic quality leadership for CMC development programs, ensuring GMP/GLP compliance with FDA, Ex-US regulatory authorities, and ICH guidelines across drug substance and drug product development.
Oversee quality operations at CDMOs and contract laboratories, 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; establish clear performance expectations, provide mentorship, and build organizational capability to support pipeline advancement and commercialization readiness.
Drive timely identification, investigation, and resolution of quality events and deviations; oversee CAPA execution and effectiveness verification to prevent recurrence.
Manage the change control process, ensuring appropriate capture of changes impacting internal procedures and regulatory filings; communicate and escalate issues with broad cross-functional impact.
Lead regulatory inspection readiness activities; serve as a senior quality representative during FDA, EMA, and other agency inspections and manage observation responses.
Contribute to CMC sections of regulatory filings (INDs, NDAs/BLAs) and support responses to agency questions in partnership with Regulatory Affairs.
Partner with CMC and Regulatory Affairs teams to align quality deliverables with pipeline milestones and program timelines.
Champion continuous improvement of quality assurance processes and procedures, leveraging data, metrics, AI tools, and cross-industry best practices.
Support implementation and optimization of electronic quality management systems (eQMS) platform; contribute to system improvement initiatives.
Maintain current knowledge of evolving regulatory expectations and industry standards; translate requirements into practical operational guidance for the organization.