Quality Systems Specialist

At Viral Vector Manufacturing Facility (VVMF) were building Australias first commercial viral vector manufacturing facility located within the countrys largest health education research and innovation precinct in Westmead.

We are seeking a motivated Quality Systems Specialist to join VVMFs growing Quality team on a six-month this role you will help maintain and improve our Quality System supporting compliance inspection readiness and operational excellence while working closely with teams across Manufacturing Quality Control Facilities Engineering and Supply Chain.

Our opportunity

Reporting to the Quality Systems Manager you will support the operation and continuousimprovement of VVMFs Quality Management System to ensure compliance with GMPrequirements and regulatory expectations.

Working as a key member of the Quality team your responsibilities will include:

• Support and continuously improve the Quality Management System (QMS) including document control SOPs deviations CAPAs change controls complaints recalls supplier quality and risk management processes.
• Coordinate internal audits inspection readiness activities and support customer and regulatory inspections including TGA audits.
• Monitor quality records compliance activities and quality metrics preparing reports and supporting governance and management review processes.
• Provide quality systems guidance to stakeholders support new and existing projects and assist with Product Quality Reviews and regulatory updates.
• Drive data integrity continuous improvement initiatives and aculture of quality compliance and operational excellence across theorganisation.

About you

To be successful in this role you will be passionate about quality compliance and continuous improvement and enjoy working collaboratively in a fast-paced GMP environment.

You will ideally bring:

• Bachelors degree in a scientific/technical discipline or equivalent Quality Systems experience.
• Experience in Quality Systems or Quality Assurance within a GMP-regulated environment.
• Strong knowledge of cGMP GMP requirements and quality system processes (e.g. deviations CAPAs change controls audits and risk management).
• Understanding of quality management and continuous improvement principles.
• Excellent attention to detail organisational problem-solving and decision-making skills.
• Strong written and verbal communication skills with the ability to build effective stakeholder relationships.
• Ability to manage multiple priorities meet deadlines and work collaboratively across teams.
• Proactive adaptable and resilient with a strong commitment to quality and compliance.

Why VVMF

• Join a mission-driven values-led organisation at the forefront of biotech innovation.
• Work in a collaborative inclusive and forward-thinking environment.
• Contribute to life-changing therapies and innovations

To Apply

Apply now via seek (including a copy of your resume and cover letter) and help unlock the future of medicine. Applications close: We encourage early applications as the role may close once a suitable candidate is appointed.

Seeking further information on this opportunity let us know via

Applicants must have the right to live and work in Australia to apply for this role and must be willing to undertake a National Police Check. Only shortlisted applicants will be contacted.