Quality Assurance Lead - Advanced Therapies

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

Quality Assurance Lead - Advanced Therapies

Western Sydney Local Health District – Westmead NSW

• Lead GMP quality assurance for innovative cell and gene therapies
• Drive regulatory submissions, quality systems and continuous improvement
• Help bring life-changing cellular therapies closer to patients

Lead quality, advance science and make a difference. Drive GMP compliance, regulatory approvals and quality system innovation in cell and gene therapy manufacturing.

Employment Type:Temporary Full Time (up to 3 years)
Position Classification:Health Manager Level 3
Remuneration: $69.35 - $78.79 per hour
Hours Per Week: 38 (Job Share may beconsidered for part time hours)
Location: Westmead Hospital

Where you'll be working
Based at Westmead Hospital, you'll join Sydney Cell and Gene Therapy (SCGT), a specialised team supporting the clinical manufacture and delivery of advanced cellular therapies for patient treatment. As personalised medicine continues to transform healthcare, SCGT plays an important role in enabling innovative therapies to meet rigorous quality and regulatory standards.

This is an opportunity to contribute to a growing advanced therapies capability within NSW Health, working at the intersection of healthcare, biotechnology, pharmaceutical manufacturing and regulatory quality.

• Purpose-driven work: Help ensure advanced cellular therapies are manufactured to the highest quality standards for patients who need them.
• Specialist environment: Apply your expertise in Good Manufacturing Practice (GMP), quality assurance and regulated manufacturing.
• Innovation and growth: Contribute to the expansion of cell therapy manufacturing capabilities and the introduction of new products.
• Collaborative partnerships: Work across manufacturing facilities to align quality systems, processes and electronic platforms.
• Professional impact: Take ownership of meaningful quality and regulatory projects in a developing area of modern medicine.

What you'll be doing
Reporting to the Quality Manager, you'll lead key quality assurance activities that maintain GMP compliance, support product release and enable the introduction of new cellular therapies. Combining hands-on quality management with strategic project delivery, you'll help strengthen the quality management system while supporting regulatory readiness and manufacturing growth.

• Lead quality management: Maintain and continuously improve the GMP-compliant quality management system, including document control, training, non-conformance management and corrective and preventive actions (CAPA).
• Strengthen audit and inspection readiness: Conduct internal audits, support external audits and regulatory inspections, and ensure findings are investigated and resolved effectively.
• Support product quality and release: Participate in batch record review and product release activities, helping ensure products meet applicable quality and regulatory requirements.
• Deliver quality system transformation: Lead the local implementation of a harmonised quality management system across partner facilities, including qualification, validation and rollout of electronic quality systems.
• Enable regulatory approvals and innovation: Prepare GMP licence application documentation, coordinate responses to regulatory agencies, and provide quality input into technology transfer, validation, change control and new product introduction.

You’ll bring a proactive, solutions-focused approach to complex quality challenges, balancing regulatory obligations and project deadlines while maintaining continuity of manufacturing operations.

Requisition ID: REQ701275
Applications Close: 25 October 2026

Discover more about theapplication process.

Review the detailedPosition Description for insights into role requirements and criteria.

Explore theselection process,employment checks,outcomes and notifications.

For inquiries about the role, contact Leighton Clancy on ***************@health.nsw.gov.au.

People with disabilities who meet the selection criteria are encouraged to apply; and where required, WSLHD will implement reasonable adjustment consistent with industry standard.

Aboriginal and/or Torres Strait Islander people are encouraged to apply. Stepping Up aims to assist Aboriginal job applicants by providing information about applying for roles in NSW Health organisations. For more information, please visit https://www.steppingup.health.nsw.gov.au/

Westmead Hospital car parking allocation model is changing. There is a waitlist for parking for new staff commencing at Westmead Hospital. This does not apply for staff with disability.

Please note: In accordance with NSW Health policy, priority will be given to Australian citizens and permanent residents. A person who is not an Australian citizen or permanent resident is only eligible for temporary employment for a period not longer than the duration of their current visa or the advertised position.