New · posted Oct 23
Nurix Therapeutics · Biotechnology
Director, Quality Assurance
- Brisbane, CA
- On-site
- Full-time
- Director
Open until filled
The role
- 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
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.
What you need
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
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.
Pay
$228,100 – $252,000 a year
Employer providedSalary Range: $228,100 - $252,000
Where you'll work
Brisbane, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Brisbane, CA
From the posting
About Nurix
Fit with Nurix Culture and Values
- Strong team orientation; highly collaborative
- Solutions and results-oriented focus
- Hands-on approach; resourceful and open to diverse points of view
About Nurix Therapeutics
Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.
Job intelligence
The context around this role
Live data · October 23, 2026
Salary intelligence
How the pay compares
This role's midpoint is 15% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Director roles in California27 roles publishing pay
Director roles in the US107 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $228,100 | — | $252,000 |
| California (middle half) | $204,000 | $219,500 | $241,000 |
| All US (middle half) | $185,500 | $209,000 | $233,750 |
This role: Nurix Therapeutics's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 23, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 927 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Nurix's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 26 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership8
- GMP and compliance7
- Lab testing and methods4
- Documentation and SOPs4
- Quality systems and risk4
- Investigations and CAPA3
- Regulatory submissions2
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- European CommissionEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules and annexes
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
Company hiring pulse
Nurix on Regulatory Jobs
- 11
- Open roles
- 11
- Distinct roles
- 1
- Locations
By discipline
- Quality6 55%
- Regulatory5 45%
By level
- Director7 64%
- Manager3 27%
- Senior & Principal1 9%
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Director, Quality Assurance at Nurix
Open until filled. $228K–$252K a year, employer provided.