Job Title

CAR-T Quality Assurance ManagerAlfred Health is a leading health care provider in Melbourne, delivering a range of services from ambulatory to inpatient and community care. In January 2026, Alfred Health will merge with Kooweerup Regional Health Service, Peninsula Health, Bass Coast Health and Gippsland Southern Health Service to form Bayside Health, creating one of the largest health services in Victoria. This role is part of that expansion and offers new training, education and career opportunities.Position Overview12month fixed term positionFull time (80 hours per fortnight + monthly ADO)Medical Scientists Grade 4, Year 15 (RZ5RZ7)Alfred Health locationAbout the CART FacilityThe CarT Facility is a newly built cleanroom at the Paula Fox Melanoma Cancer Centre (PFMCC) that produces innovative cell and gene immunotherapies for clinical research. It operates under Good Manufacturing Practice (GMP) and a comprehensive Quality Management System.The RoleSupport the aims and objectives of the Quality Department and advance the implementation of quality objectives.Ensure compliance with cGMP, PIC/S, OGTR and relevant clinical regulatory requirements.Manage the GMP training program, inducting new staff and continually developing training.Provide guidance, interpretation and training on regulations, guidelines and company policies related to manufacturing and testing of cellular and tissue therapies.Oversee deviation management, OOS investigations, CAPA, change control, equipment management, document control and riskmanagement systems.Perform internal and vendor/supplier audits, write reports, and follow up on corrective/preventative actions.Conduct investigations and develop risk assessments 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 act as delegate for QA approval of Product Batch Release.Participate in quality improvement activities including internal audits, nonconformance investigations, OOS, OOT and operational change plans.Lead onsite customer and regulatory agency audits.Use a variety of computerbased applications (MS Word, Excel, PowerPoint, Outlook, eQMS, BMS/EMS).Be flexible to participate in planned operational tasks on weekends and overtime as necessary; participate in an oncall roster where applicable.Communicate effectively and professionally with clients, regulatory authorities and staff members.Provide expert advice to external and internal stakeholders on quality and regulatory matters.Essential Qualifications and ExperienceKnowledge, direct experience and understanding of Good Manufacturing Practice codes for biologics or pharmaceuticals (TGA, PIC/S, FDA or EMA).Relevant scientific qualification or equivalent (e.g. graduate qualifications in biological sciences).Extensive experience working with a quality system in a regulated environment within biologics or pharmaceuticals.Experience in riskmanagement processes and the ability to make decisions based on risk.Demonstrated ability to lead audits, lead a team and facilitate personal development.Effective communication skills (verbal, written, presentation) in English.Ability to achieve results through problemsolving, decisionmaking, prioritisation, organisation and time management.Willingness to perform tasks at all levels.DesirableRecognised Lead Auditor (Quality Systems) qualification.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 BenefitsSalary packaging & novated leasing through Maxxia.Flexible health insurance coverage through HCF Health Insurance.Onsite car & bike parking (deducted pretax; subject to availability).Facilities for fitness (ProSport health and fitness).Childcare services managed by KU Children''s Services.Contact: Wendy Fleming, Head of Manufacturing - CART [email protected] close 11:00 pm AEDT, Sunday 11 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.In accordance with the Health Services Amendment (Mandatory Vaccination of Healthcare Workers) Act 2020, health care workers in Category A or B roles are required to be vaccinated against influenza or hold an acceptable medical exemption.Website: www.alfredhealth.org.au #J-18808-Ljbffr