GMP QA Director, CDMO Partnerships & Clinical Materials

Nurix Therapeutics; Brisbane (CA); Sur place; USD 228 000 - 252 000; Plein temps

Résumé du poste

Nurix Therapeutics is seeking a Lead GMP Quality Assurance professional to direct QA for our small molecule CMC programs and to serve as the primary interface with CDMOs and contract laboratories. You will ensure quality, timely supply of clinical materials, and inspection readiness while building and mentoring the QA team as we advance late-stage development toward commercialization.

You will provide strategic quality leadership across CMC development, ensuring GMP compliance with FDA, ICH

Qualifications

• Bachelor's degree in chemistry, pharmaceutical sciences, life sciences, or related field.
• 12+ years of progressive QA experience in the pharmaceutical or biopharmaceutical industry, with leadership experience.
• Deep GMP knowledge for small molecule drug substances and drug product across development stages.
• Experience managing CDMO relationships and overseeing QA operations at contract manufacturers and laboratories.
• Strong knowledge of FDA regulations (21 CFR Parts 210/211), ICH guidelines (Q7–Q11), and GMP compendia.
• Proven track record leading quality events, deviations, CAPA, and change control in clinical or commercial settings.
• Experience supporting regulatory inspections (FDA/EMA or equivalent); leading QA during pre-approval inspections preferred.
• Ability to lead, develop, and motivate QA teams in a fast-paced, clinical-stage environment.
• Excellent project management and cross-functional collaboration skills.
• Willingness to travel domestically and internationally to CDMOs and labs.

Responsabilités

• Provide strategic QA leadership for CMC programs ensuring GMP compliance across development
• Oversee quality operations at CDMOs including deviations, investigations, batch records, and CAPA
• Lead and mentor QA professionals; set clear performance expectations
• Support regulatory inspection readiness and respond to agency observations
• Contribute to CMC sections of INDs/NDAs/BLAs with Regulatory Affairs
• Support eQMS implementation and platform improvements
• Translate evolving regulatory expectations into practical operational guidance

Connaissances

GMP knowledge

QA leadership

CDMO management

Regulatory knowledge (FDA/ICH)

CAPA & deviations

Inspection readiness

Project management

Communication

Travel readiness

Formation

Bachelor's degree in chemistry or related field

Outils

Veeva Vault / eQMS

Description du poste

Nurix Therapeutics is seeking a Lead GMP Quality Assurance professional to direct QA for our small molecule CMC programs and to serve as the primary interface with CDMOs and contract laboratories. You will ensure quality, timely supply of clinical materials, and inspection readiness while building and mentoring the QA team as we advance late-stage development toward commercialization.

You will provide strategic quality leadership across CMC development, ensuring GMP compliance with FDA, ICH