Quality Assurance Lead

What you'll be doing

The Quality Assurance Lead will work within the exciting, NSW Department of Health funded, clinical grade viral vector manufacturing initiative, for the generation of gene-based therapeutics.


The Quality Assurance Lead will assist in the establishment and maintenance of a comprehensive cGMP Quality Management System to manufacture AAV- and LV-based vectors. The Quality Assurance Lead will report to the Quality Manager and work closely with the Process Development Upstream and Downstream Leads and GMP Production Manager.

• Appropriate tertiary qualifications in a related field Science, Pharmacy or other health related discipline or demonstrated, relevant, equivalent professional experience
• Demonstrated GMP experience in pharmaceutical/biotech or other regulated industry
• Demonstrated experience dealing with OOS, change control, deviations, risk assessments and batch release
• Demonstrated experience with managing external suppliers, contract manufacturers and testing laboratories
• Demonstrated experience in preparation of high-quality documentation including but not limited to SOPs and Quality agreements
• High attention to detail with excellent interpersonal and time management skills
• Experience in method validation and working in a QC laboratory

All NSW Health workers are required to have completed a primary course (2 doses) of a COVID-19 vaccine which has been approved or recognised by the Therapeutics Goods Administration (TGA). New applicants must have completed the vaccination course prior to commencement with NSW Health, or provide an approved medical contraindication certificate (IM011 immunisation medical exemption form) certifying the worker cannot have any approved COVID-19 vaccines available in NSW. Acceptable proof of vaccination is the Australian Immunisation Register (AIR) Immunisation History Statement or AIR COVID-19 Digital Certificate. Booster doses are highly recommended for all health care workers who have completed the primary course of COVID-19 vaccinations. Applicants holding visas with working rights may be considered for temporary appointment (up to the expiry date of their visa) where no suitable local applicant is identified.

For technical support please contact the customer services team on 1300 679 367 and select option 3.

Applications Close: 25/02/2024