QA Lead - Cell & Gene Therapies (GMP & Regulatory)

Western Sydney Local Health District; Sydney; On-site; AUD 95,000 - 109,000; Full time

Job summary

Western Sydney Local Health District at Westmead Hospital is seeking a Quality Assurance Lead for Advanced Therapies to steer GMP quality assurance, regulatory readiness and innovative quality systems. You will oversee audits, product release, and the introduction of new cellular therapies in a compliant manufacturing environment.

The role, based at Westmead Hospital within the Sydney Cell and Gene Therapy team, offers leadership in quality assurance for advanced therapies and opportunities to

Responsibilities

• Lead GMP quality assurance and maintain the GMP‑compliant quality management system.
• Conduct internal audits, support external audits and regulatory inspections, and ensure findings are resolved.
• Participate in batch record reviews and product release to meet quality and regulatory requirements.
• Drive the rollout of a harmonised electronic quality system across partner facilities.
• Prepare GMP licence documentation and coordinate regulator responses for technology transfer and new product introductions.

Job description

Western Sydney Local Health District at Westmead Hospital is seeking a Quality Assurance Lead for Advanced Therapies to steer GMP quality assurance, regulatory readiness and innovative quality systems. You will oversee audits, product release, and the introduction of new cellular therapies in a compliant manufacturing environment.

The role, based at Westmead Hospital within the Sydney Cell and Gene Therapy team, offers leadership in quality assurance for advanced therapies and opportunities to