Director, GxP Quality & Supplier Excellence

Regulatory Jobs

Brisbane (CA)

Presencial

USD 244.000 - 263.000

Jornada completa

Hace 3 días
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Descripción de la vacante

Nurix Therapeutics is seeking a Director, Quality Compliance and Supplier Quality to lead GxP programs including audits, supplier oversight, complaints, recalls, and inspection readiness.

You will build and run risk-based quality systems across CDMOs and suppliers, apply ICH guidelines, and coordinate with QA, Regulatory Affairs, and Clinical Operations.

This leadership role requires strategic vision and hands-on execution to advance late-stage development toward commercialization.

Formación

  • Bachelor’s degree in chemistry, pharmaceutical sciences, life sciences, engineering, or a related field.
  • 10+ years of QA/Quality Compliance in pharma with at least 5 years leading audit or supplier programs.
  • Experience managing supplier qualification, CDMOs/CROs, and external audits.
  • Proven track record with FDA/EMA inspections and risk-based quality systems.

Responsabilidades

  • Own end-to-end internal and external GxP audits and CAPA programs.
  • Lead supplier qualification, lifecycle management, and ASL maintenance.
  • Oversee complaints, recalls, and inspections readiness activities.
  • Collaborate with cross-functional partners and external auditors.

Conocimientos

Leadership
Audit management
Regulatory knowledge
Quality systems

Educación

Bachelor’s degree (chemistry, pharmaceutical sciences, life sciences, engineering)

Descripción del empleo

Nurix Therapeutics is seeking a Director, Quality Compliance and Supplier Quality to lead GxP programs including audits, supplier oversight, complaints, recalls, and inspection readiness.

You will build and run risk-based quality systems across CDMOs and suppliers, apply ICH guidelines, and coordinate with QA, Regulatory Affairs, and Clinical Operations.

This leadership role requires strategic vision and hands-on execution to advance late-stage development toward commercialization.

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