GMP Quality Manager

Alfred Health

Alfred Health is a leader in health care delivery, improvement, research and education. We are the main provider of health services to people living in the inner southeast suburbs of Melbourne, from ambulatory to inpatient and home and community-based services. On 1 January 2026, Alfred Health will come together with Kooweerup Regional Health Service, Peninsula Health, Bass Coast Health and Gippsland Southern Health Service to create Bayside Health, a newly merged health service with more than 22,000 employees caring for a community of over 1.2 million Victorians. The new health service will provide people with the best possible care with services that support them throughout their lives. The merger will also strengthen our workforce, providing new training, education and career opportunities. Subject to final approval on 1 January 2026, all employees from the five health services will transfer to Bayside Health.

• 12-month fixed term position
• Full time (80 hours per fortnight + monthly ADO)
• Medical Scientists Grade 4, Year 1-5 (RZ5-RZ7)
• Alfred Health location
• Great staff benefits!

The Department

The Chimeric Antigen Receptor T-cells (CAR-T) Facility is a newly built cleanroom facility at the Paula Fox Melanoma Cancer Centre (PFMCC). The facility will manufacture innovative cell and gene immunotherapies for patient care in the context of clinical research.

The PFMCC CAR-T Facility will operate under the Good Manufacturing Practices (GMP) framework under a Quality Management System in accordance with current government regulations and other applicable standards, including Alfred Health policies.

The CAR-T Quality Assurance Manager will be responsible for driving, establishing and maintaining the GMP Quality System. The position requires risk-based decision-making capability and leadership competency.

The Role

• Support the aims and objectives of the Quality Department and actively progress the implementation of the quality objectives
• Ensure compliance with cGMP, PIC/S, OGTR and relevant clinical regulatory requirements
• Managing the GMP training program to ensure that all new staff are inducted into the requirements of the QMS related to their roles and responsibilities and progressing the continued development of the training program
• Providing guidance, interpretation, support, training, and input on the regulations, guidelines, company procedures and policies relating to the manufacturing and testing of cellular and tissue therapies
• Provide oversight of deviation management, OOS investigations, CAPA, change control, equipment management, document control, and risk‑management systems, as well as other relevant quality systems, to support timely resolution of production‑impacting issues
• Perform Internal and Vendor/Supplier Audits, write reports, review and follow-up on corrective/preventative actions
• Conduct investigations and develop risk assessments in collaboration with manufacturing to resolve quality issues and suggest process improvements
• Monitor, manage and report QMS metrics for Quarterly Quality Reviews 
• Maintain Batch Record systems and perform as Delegate for QA approval of Product Batch Release 
• Participate in quality improvement activities in accordance with the Quality Management System, including but not limited to, internal audits, non-conformance investigations, OOS, OOT and operational change plans
• Leading on site customer and regulatory agency audits
• Use of a variety of computer-based applications (MS Word, Excel, PowerPoint Outlook, eQMS, BMS/EMS)
• Flexibility to participate in planned operational tasks on weekends and overtime as necessary; Participate in an on-call roster where applicable
• Effective and professional communication with clients, regulatory authorities, and staff members
• Provide expert advice to external and internal stakeholders relating to relevant quality and regulatory matters

Qualifications and Experience Required

Essential

• Knowledge, direct experience and understanding of the codes of Good Manufacturing Practice for biologics (biologicals) or pharmaceuticals as documented by TGA, PIC/S, FDA or EMA
• Appropriate qualifications in a relevant scientific discipline or equivalent such as recognized graduate qualifications in biological sciences.
• Extensive and demonstrable experience of working with a quality system, in a regulated environment in the field of biologics or pharmaceuticals.
  • Experience in risk management processes and an ability to make decisions based on risk and provide sound justification.
  • Demonstrated ability to lead audits, lead a team and facilitate personal development
• Effective and professional communication skills (verbal, written and presentation skills in English)
• Ability to achieve results through problem solving, decision making, prioritisation, organisation and time management
• Willingness to perform tasks at all levels

Desirable      

• Recognised Lead Auditor (Quality Systems) qualifications
• Minimum of 5 years’ experience in the manufacture of human blood, tissues or cellular therapy products under cGMP conditions using scalable processes for human therapy

Staff Benefits

• Salary packaging & novated leasing through Maxxia
• Flexible health insurance coverage through HCF Health Insurance
• Onsite car & bike parking opportunities, deducted pre-tax *subject to availability
• Fantastic onsite fitness facilities at The Alfred through ProSport health and fitness
• Childcare services at The Alfred managed by KU Children’s Services

If applicable, please specify specific requirements that you require in your cover letter or CV.

For enquiries regarding this position, please contact Wendy Fleming, Head of Manufacturing - CAR-T - W.Fleming@alfred.org.au

Applications close 11pm AEDT, Sunday 11th January 2026.

We embrace diversity and strive to have a workforce that reflects the communities we serve. We actively encourage applications from Aboriginal and Torres Strait Islander people, people with disability, and people of all genders, sexualities, and cultural backgrounds.

If you require adjustments to the recruitment and selection process, or require an alternative format to any of the application materials, please don’t hesitate to get in touch with the contact person listed on this ad.

In accordance with the Health Services Amendment (Mandatory Vaccination of Healthcare Workers) Act 2020, health care workers in Category A or B roles (as determined by the department’s risk ratings) are required to be vaccinated against influenza or hold an acceptable medical exemption. 

Website: www.alfredhealth.org.au