Associate Director, Quality Management – Translational Medicine Oncology

Job description

Join Early Oncology’s Translational Medicine (TM) Global Operations team to drive on quality across our Translational Medicine and Biomarker Science & Technology (BST) organizations, including Labs, Biomarker Operations, and Translational Strategy. As a key quality partner , y ou will advise on compliance and risk, lead continuous improvement, and champion a culture of quality excellence that delivers high-quality science to patients . Key Responsibilities: Review, assess, and communicate the status of the Quality Management System (QMS) for TM and BST teams, partnering with stakeholders and business process owners to recommend continuous improvements aligned to AZ Global Standards, ICH GCP and relevant GxP where applicable . Provide first line quality and compliance advice to enable risk identification, change control, deviation management, CAPA effectiveness, and timely issue resolution. Conduct targeted self inspections and laboratory spot checks; analyze trends and drive preventive actions . Author, maintain , and simplify quality SOPs, work instructions, and records; partner with process owners to measure effectiveness and adopt fit for purpose controls. Champion an engaging q...