Director, Quality Compliance and Supplier Quality

The role

The Director, Quality Compliance and Supplier Quality will lead quality programs including audits, supplier oversight, complaints, recalls, and inspection readiness. This role ensures GxP compliance across CDMOs, contract laboratories, and suppliers during late-stage clinical development and toward commercialization.

What you will do

• Provide strategic leadership for the quality compliance program
• Apply a risk-based compliance framework using ICH principles
• Maintain quality metrics, KPIs, and trending
• Own the internal audit program end to end
• Establish and manage the external GxP audit program
• Own the end-to-end supplier lifecycle for GxP suppliers and service providers
• Own the product quality complaint handling program
• Own the product recall, retrieval, and market action procedures
• Lead the company-wide regulatory inspection readiness program
• Establish and maintain a structured regulatory intelligence process

Required qualifications

• Bachelor’s degree in chemistry, pharmaceutical sciences, life sciences, engineering, or a related field
• 10+ years of progressive Quality Assurance or Quality Compliance experience in the pharmaceutical or biopharmaceutical industry
• At least 5 years leading audit, supplier quality, or compliance programs
• Demonstrated experience building or managing supplier qualification and audit programs, including oversight of CDMOs, contract laboratories, and CROs
• Thorough working knowledge of FDA regulations (21 CFR Parts 11, 210/211, 312, 314), 21 CFR Part 7 (recalls), and ICH guidelines (E6(R3), Q7, Q8, Q9(R1), Q10, Q11, Q12), as well as EudraLex Volume 4 (i
• Proven experience with product complaint handling and CAPA programs in a clinical or commercial setting
• Experience supporting or leading regulatory agency inspections (FDA, EMA, or equivalent)
• Lead auditor experience for GxP audits (on-site and remote) with strong report-writing and observation-classification skills
• Demonstrated ability to lead, develop, and motivate teams in a fast-paced, ambiguous environment
• Excellent project management skills
• Strong verbal and written communication skills
• Willingness to travel to CDMO, supplier, and laboratory sites domestically and internationally, as needed (estimated [10-20]%)

Nice to have

• 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 QMS) and document management systems
• Experience with GLP and GCP supplier oversight, and with clinical supply chain and GDP requirements
• Professional certifications such as ASQ Certified Quality Auditor (CQA), ASQ Certified Pharmaceutical GMP Professional (CPGP), or equivalent lead auditor training
• Experience supporting virtual or outsourced manufacturing models

About the company

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines. The company uses an AI-integrated discovery engine to develop treatments for cancer and inflammatory diseases.