QA Lead, Advanced Therapies — Drive GMP & Compliance

NSW Health; Sydney; On-site; AUD 95,000 - 109,000; Full time

Job summary

NSW Health is seeking a Quality Assurance Lead for Advanced Therapies at Westmead Hospital. You will lead GMP QA, drive regulatory submissions, and advance quality systems within a growing cell and gene therapy program.

Reporting to the Quality Manager, you will balance hands-on QA with strategic project delivery, strengthening the QMS and enabling manufacturing growth while ensuring regulatory readiness.

Qualifications

• GMP manufacturing or transplantation QA experience.
• High-level understanding of regulatory requirements for GMP manufacture.
• Experience preparing licence applications or variations.

Responsibilities

• Lead GMP-compliant quality management system improvements and document control.
• Support internal and external audits and regulatory inspections.
• Participate in batch record review and product release activities.
• Lead the rollout of harmonised electronic quality systems across partner facilities.
• Provide quality input into technology transfer, validation and change control.

Skills

GMP quality assurance

Regulatory compliance

Quality management system

Internal audits

CAPA

Project leadership

Education

Degree in a relevant scientific discipline

Tools

Computerized validation

Job description

NSW Health is seeking a Quality Assurance Lead for Advanced Therapies at Westmead Hospital. You will lead GMP QA, drive regulatory submissions, and advance quality systems within a growing cell and gene therapy program.

Reporting to the Quality Manager, you will balance hands-on QA with strategic project delivery, strengthening the QMS and enabling manufacturing growth while ensuring regulatory readiness.