Director, GxP Quality & Supplier Excellence

Nurix Therapeutics; Brisbane (CA); Presencial; USD 244.000 - 263.000; Jornada completa

Descripción de la vacante

Nurix Therapeutics is seeking a Director of Quality Compliance and Supplier Quality in Brisbane, CA, responsible for leading GxP audit programs, supplier qualification, complaint handling, recalls, and inspection readiness. This leader will mentor a team of quality professionals and collaborate across Quality, CMC, Clinical Operations, and Supply Chain.

You will apply ICH and FDA guidelines to risk-based oversight of CDMOs, contract labs, and suppliers, ensuring robust quality and regulatory

Formación

• Bachelor’s degree in chemistry, pharmaceutical sciences, life sciences, engineering, or a related field.
• 10+ years QA or Quality Compliance experience in the pharmaceutical or biopharmaceutical industry, including 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)
• 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
• Willingness to travel to CDMO, supplier, and laboratory sites domestically and internationally, as needed (estimated [10-20]%)

Responsabilidades

• Own internal audit program end-to-end: annual, risk-based audit schedule; audit planning and scope; execution; reporting; CAPA verification; and program governance
• Audit internal GxP processes and systems (e.g., deviation and CAPA management, change control, document control and records management, training, batch record and lot disposition review, data integrity, computerized systems, and clinical supply operations)
• Track and trend audit observations to identify systemic issues; drive remediation with process owners and verify effectiveness of corrective and preventive actions
• Establish auditor qualification, training, and independence requirements; manage internal auditors and any qualified third-party auditors
• Use audit results and trend data to prioritize quality system improvements and inform inspection readiness activities
• Lead the external GxP audit program and coordinate audits of Nurix suppliers; drive CAPA to closure and escalation as needed
• Support mock inspections and pre-inspection activities at CDMOs ahead of regulatory filings
• Coordinate with Qualified Person (QP) service providers to support regulatory certifications
• Manage audit calendar, resources, and budget; maintain audit reports and certificates in the eQMS
• Support partner audits and commitments tracking

Conocimientos

Quality leadership

GxP compliance

Audit management

Regulatory knowledge

Lead auditor

Cross-functional collaboration

Project management

Communication

Travel readiness

Educación

Bachelor's degree in life sciences or related field

Herramientas

Veeva Vault QMS

Descripción del empleo

Nurix Therapeutics is seeking a Director of Quality Compliance and Supplier Quality in Brisbane, CA, responsible for leading GxP audit programs, supplier qualification, complaint handling, recalls, and inspection readiness. This leader will mentor a team of quality professionals and collaborate across Quality, CMC, Clinical Operations, and Supply Chain.

You will apply ICH and FDA guidelines to risk-based oversight of CDMOs, contract labs, and suppliers, ensuring robust quality and regulatory