ClinicalQualityAssociateDirector

Do you have expertise in clinical trial quality, and a passion for Cell Therapy? Are you ready to play a pivotal role in crafting frontline quality management for clinical studies in a fast paced and innovative area? Join a company that follows the science and turns ideas into life-changing medicines - AstraZeneca might be the one for you! ## **About AstraZeneca** ## AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in four therapy areas – Oncology; Cardiovascular, Renal and Metabolism (CVRM); Respiratory & Immunology (R&I); and Rare Disease. Within Oncology R&D, AstraZeneca is investing in our internal capabilities to help us realise our ambition to become leaders in the delivery of next-generation cellular therapies. Leveraging historical expertise in biologics engineering, gene editing and immunology across solid and haematological malignancies, we are uniquely positioned to develop cutting-edge technologies to advance cell therapies in cancer treatment. ## **What you’ll do** As an Associate Director, Clinical Quality based in Sydney, you will join the Cell Therapy Clinical Operations (CTCO) Business Processes, Quality & Learning (BPQL) team, as part of the first-line quality pillar. Reporting to the Senior Director Cell Therapy BPQL, you will lead _regional_ quality oversight activities for SMM, embedding GCP-aligned practices, driving training compliance and helping to develop quality metrics that surface risks early. You will partner closely with SMM leadership, process owners and learning leads to provide expert quality advice and coaching, ensuring operational teams maintain high quality standards and are inspection-ready. Key responsibilities: * **First-line quality oversight** : provide direction and advice to Cell Therapy SMM teams on applying ICH-GCP, AZ standards and SOPs; support country leadership to plan and