Senior Director, GMP QA - CMC for Small Molecules

BioSpace; Brisbane (CA); Vor Ort; USD 228.000 - 252.000; Vollzeit

Zusammenfassung

Nurix Therapeutics is seeking a Lead GMP Quality Assurance professional to steer quality across small molecule CMC programs. You will serve as the primary QA interface with CDMOs and contract laboratories, ensuring GMP compliance and inspection readiness.

You will lead a QA team, drive CAPA programs, and contribute to regulatory filings while aligning quality deliverables with program milestones in a fast-paced, clinical-stage environment.

Qualifikationen

• 12+ years of progressive Quality Assurance experience with leadership in pharma/biopharma.
• Bachelor's degree in chemistry, pharmaceutical sciences, life sciences, or related field.
• Deep GMP expertise for small molecule substances and products across development stages.
• Experience managing CDMO relationships and QA operations at contract manufacturers/labs.
• Knowledge of FDA 21 CFR Parts 210/211, ICH Q7-11, and EudraLex GMP guidelines.
• Proven track record leading QA events, deviations, CAPA, and change control.
• Regulatory inspection experience (FDA/EMA); lead QA during pre-approval inspections is a plus.

Aufgaben

• Provide strategic QA leadership for CMC development programs and ensure GMP compliance.
• Serve as primary QA interface with CDMOs and external labs; oversee deviations, investigations, batch records, and lot disposition.
• Lead and develop the QA team; set performance expectations and build capability for pipeline advancement and commercialization readiness.
• Drive timely identification and resolution of quality events; oversee CAPA execution and effectiveness verification.

Kenntnisse

QA leadership

GMP compliance

cross-functional collaboration

Ausbildung

Bachelor's degree in chemistry, pharmaceutical sciences, life sciences

Tools

Veeva Vault

Jobbeschreibung

Nurix Therapeutics is seeking a Lead GMP Quality Assurance professional to steer quality across small molecule CMC programs. You will serve as the primary QA interface with CDMOs and contract laboratories, ensuring GMP compliance and inspection readiness.

You will lead a QA team, drive CAPA programs, and contribute to regulatory filings while aligning quality deliverables with program milestones in a fast-paced, clinical-stage environment.