Director, Quality Assurance

Nurix • Brisbane, CA

1d • Onsite

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, inspection readiness, and development of the QA team as programs advance through late-stage development toward commercialization. Reporting to the Senior Vice President, Quality, this high-visibility position works across Quality, CMC, Regulatory Affairs, and external manufacturing partners in a dynamic clinical-stage environment, combining strategic leadership with hands-on execution.

The Director will provide quality leadership across CMC development programs, ensure GMP compliance, oversee external quality operations, and support regulatory filings and agency inspections. The role also leads and mentors QA professionals, supports eQMS implementation and improvement, and translates evolving regulatory requirements and industry standards into practical organizational guidance.

Requirements

• Bachelor's degree in chemistry, pharmaceutical sciences, life sciences, or a related field.
• 12 or more 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 and practical application of FDA regulations (21 CFR Parts 210/211), ICH guidelines (Q7, Q8, Q9, Q10, Q11), and EudraLex Volume 4 (GMP) 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, including FDA, EMA, or equivalent.
• 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 as the lead QA representative during pre-approval inspections.
• 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 the Quality Assurance team, establish 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, and oversee CAPA execution and effectiveness verification.
• Support change control, ensure 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 regulatory filings, including INDs and NDAs/BLAs, in partnership with Regulatory Affairs.
• 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) and contribute to system improvement initiatives.
• Maintain knowledge of evolving regulatory expectations and industry standards and translate requirements into practical operational guidance.
• Travel domestically and internationally to CDMO and laboratory sites as needed.

What This Job Offers

• Job Type: Full-time
• Career Level: Director