Quality Assurance Manager

Join our passionate team in Mount Kuring‑Gai as a Quality Assurance Manager and play a key role in ensuring excellence Reporting to the Director of Regulatory, Medical Affairs and Quality Management, you will oversee compliance with cGMP and global standards, manage quality documentation, drive continuous improvement, qualify external service providers, and handle customer complaints across Australia and New Zealand. Responsibilities Quality Management System and Documentation: Ensure the local Quality Management System complies with cGMP, TGA, Medsafe, ISO 9001, ISO 13485 and global SOPs, while driving efficiency through improved systems and processes. Lead internal and external audits, manage continual improvement projects, conduct regular Quality Management Reviews and provide QA support for third‑party manufacturing activities such as stability studies, batch reviews and change management. Prepare and maintain Quality Management documents – including SOPs, work instructions, policies, agreements, risk assessments and validation records – ensuring accuracy, currency and compliance with applicable standards and business requirements. Customer and Supplier Complaint Resolution: Take ownership of the entire process, from logging and tracking issues to liaising with stakeholders and arranging sample transport, while ensuring compliance with handling requirements. Prepare clear, professional responses to deliver timely and effective solutions. Team Leadership: Lead and develop a high‑performing team, providing day‑to‑day guidance, fostering open communication, recognising achievements and addressing performance issues promptly. Ensure adequate staffing, identify training needs, support career development and conduct regular performance reviews. Knowledge and Compliance: Maintain up‑to‑date knowledge of cGMP, PIC/S, TGA, Medsafe, ISO 9001, ISO 13485, MDSAP audit criteria and Quality Management System requirements. Ensure compliance with Fresenius Kabi global SOPs, policies and relevant legislation. Adhere to ethical standards and reporting obligations, including timely reporting of adverse drug reactions, medical device events and product complaints within one business day. Proficiency in Microsoft Word, Excel and Visio is required. Qualifications Excellent communication skills, both written and oral. Previous experience in pharmaceutical manufacturing or a related production environment. Knowledge of GMP, PIC/S, ISO 9001, TGA and Medsafe. Previous experience in a Quality System management role. Knowledge of Drugs, Poisons and Controlled Substances Regulations (desirable). Experience in Microsoft Word, Excel and Visio (desirable). Benefits Competitive base salary, vehicle allowance and an incentive program. Flexible working environment and arrangements. A culture focused on personal development and health and wellbeing. Various lifestyle and support programs for employees, including EAP, study support and reward and recognition programmes. Company Overview At Fresenius Kabi, we have a singular purpose – Advancing Patient Care. This corporate philosophy enables us to provide the highest‑quality medicines and technologies to those in need. Our product portfolio includes a comprehensive range of I.V. generic drugs, infusion therapies and clinical nutrition products, as well as devices for administering these products. In gastroenterology, we supply market‑leading products essential for preparing patients for colonoscopies. Within transfusion medicine and cell therapies, we offer products for the collection of blood components and extracorporeal therapies. Equal Employment Opportunity We are committed to equal employment opportunity for everyone, regardless of age, gender, ability, race, religion, sexual orientation, or ethnicity. We encourage applications from all, including those of Aboriginal or Torres Strait Islander descent. For more information about Fresenius Kabi Australia, please visit our website: . #J-18808-Ljbffr