Quality Control Lead

• Lead the establishment of a GMP-aligned QC testing laboratory
• Shape quality systems supporting cell and gene therapy innovation
• Join a pioneering program transforming clinical therapeutics

Build and lead GMP-compliant QC testing for cell and gene therapies, enabling reliable clinical release and advancing innovative treatments.
 

Employment Type: Temporary Full Time (up to 12 months)
Position Classification: Health Manager Level 2
Remuneration: $59.92 - $70.70 per hour
Hours Per Week: 38
Location: Westmead Hospital

Where you'll be working
Located at Westmead Hospital, Sydney Cell and Gene Therapy (SCGT) is bringing together clinical expertise, research and emerging advanced therapies to strengthen cell and gene therapy capability across the Westmead campus.

You’ll join a collaborative, multidisciplinary environment where quality, innovation and patient outcomes are at the heart of the work.

• Be part of the Westmead Research Hub and a growing cell and gene therapy ecosystem.
• Work across established human cell transplantation services and emerging gene therapy programs.
• Help establish a centralised QC testing capability supporting clinical release of therapeutic products.
• Collaborate with scientists, clinicians, quality professionals and other specialist stakeholders.
• Contribute to a culture focused on excellence, innovation, safety and improving patient outcomes.

What you'll be doing
As Quality Control Lead, you’ll take a key leadership role in establishing and operating the QC laboratory that will underpin clinical release of cell and gene therapies. You’ll combine technical expertise, quality leadership and operational management to build robust, compliant and fit-for-purpose testing capability.

• Lead day-to-day QC laboratory operations, supervising staff and coordinating testing priorities across stakeholder groups.
• Develop, transfer and validate analytical and product testing procedures from research environments into robust, reproducible GMP processes.
• Ensure QC testing, documentation, data integrity, archiving and retention meet GMP, cGMP and SCGT Quality Management System requirements.
• Establish specifications, sampling processes, reference standards, retention samples and stability programs that support clinical release.
• Partner with internal teams and third parties to maintain compliant quality arrangements and deliver testing within critical turnaround times and project milestones.

Make a difference with NSW Health
Lead quality excellence in cell and gene therapy and help shape the future of healthcare. Join NSW Health to innovate, collaborate and improve patient outcomes.

Ready to make an impact at the intersection of GMP, advanced therapies and clinical care? Apply now.

How to Apply
Apply online by submitting your resume and addressing the criteria listed below by providing examples that demonstrate your ability before the closing date.
 

Selection Criteria:

1. Bachelor of Science Degree in the physical or biological sciences or extensive equivalent experience.
2. Prior experience in a cGMP regulated industry, preferably in biological or pharmaceutical drug development.
3. Knowledge and experience in performing analytical techniques used in tissue culture, flow cytometry, ELISA’s and PCR and good Aseptic techniques appropriate for sampling and testing of sterile products and aseptic facilities.
4. Experience with TGA guidelines with the ability to understand and interpret cGMP guidelines regarding quality control activities and drug development processes and familiarity with ICH guidelines will be highly regarded.
5. Excellent organisational, record keeping, and project management skills and ability to manage competing deadlines.
6. A high standard of written and verbal communication skills with all levels of employees and demonstrated ability to work effectively both independently and within a dynamic team environment.
7. Excellent attention to detail and proven flexibility and adaptability.
8. Advanced computer system skills are required and experience with Ideagen’s Q-Pulse quality management software will be highly regarded.

Requisition ID: REQ689437
Applications Close: 17 September 2026

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