Quality Assurance Lead - Advanced Therapies

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

Quality Assurance Lead - Advanced Therapies

• 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.

• Degree in a relevant scientific discipline or equivalent experience in quality assurance within a regulated environment.
• Demonstrated experience in quality assurance within a regulated laboratory environment such as GMP manufacturing or transplantation services.
• High‑level understanding of TGA and other relevant regulatory requirements for GMP manufacture, with demonstrated experience preparing licence applications, variations or other regulatory submissions.
• Demonstrated experience with quality system implementation and/or computer system validation.
• Experience conducting internal audits and supporting external regulatory audits or inspections.
• Demonstrated ability to lead complex projects involving multiple internal and external stakeholders and deliver to agreed timelines.
• Excellent verbal and written communication and interpersonal skills demonstrated with a wide variety of stakeholders.

Requisition ID: REQ701275
Applications Close: 25 October 2026

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.