Senior QA Director: GMP & CMC for Clinical Programs

Nurix; Brisbane (CA); Presencial; USD 228.000 - 252.000; Jornada completa

Descripción de la vacante

Nurix Therapeutics in Brisbane, CA is seeking a Lead GMP Quality Assurance leader for small molecule CMC programs. You will be the primary QA interface with CDMOs, ensure GMP compliance, and maintain inspection readiness while mentoring the QA team.

You will drive CAPA, change control, and regulatory support for INDs/NDAs, partnering with Regulatory Affairs and contributing to eQMS improvements. Travel to CDMO sites is expected.

Formación

• Extensive GMP QA experience in pharma/biopharma environments.
• Proven leadership of QA teams in clinical-stage or late-stage programs.
• Deep knowledge of FDA regulations and GMP principles in CMC development.
• Experience managing CDMOs and external labs.
• Regulatory inspection experience (FDA/EMA); lead during pre-approval inspections favored.

Responsabilidades

• Lead QA for small molecule CMC programs and ensure GMP compliance across development.
• Oversee deviations, investigations, CAPA programs, and change control.
• Partner with Regulatory Affairs for regulatory filings and inspection responses.
• Mentor and grow the QA team and drive inspection readiness across sites.
• Support eQMS implementation and cross-functional quality improvements.

Conocimientos

GMP knowledge

Quality leadership

CDMO management

FDA regulations

Regulatory inspections

CAPA management

Change control

eQMS (Veeva)

Team mentoring

Project management

Communication skills

Travel readiness

Educación

Bachelor's degree in chemistry/pharma

Herramientas

Veeva Vault

Descripción del empleo

Nurix Therapeutics in Brisbane, CA is seeking a Lead GMP Quality Assurance leader for small molecule CMC programs. You will be the primary QA interface with CDMOs, ensure GMP compliance, and maintain inspection readiness while mentoring the QA team.

You will drive CAPA, change control, and regulatory support for INDs/NDAs, partnering with Regulatory Affairs and contributing to eQMS improvements. Travel to CDMO sites is expected.