Specialist, PDM Program Expert

Overview In this role, you contribute to the Quality Management Digital (QM D) function by translating regulatory and business needs into compliant processes, training, and qualification solutions. You work with cross-functional teams across R D quality and regulatory affairs to enhance the Quality Management System and ensure end-to-end process integrity. You will drive ARR and Quality Framework initiatives, and support transformation programs that enable compliant, efficient R D activities. This position offers visibility across global functions and a chance to shape quality and learning solutions in a fast-paced environment. Leistungen / Benefits Hybrid work arrangement Learning, innovation, and professional development opportunities Verantwortungsbereiche Lead and contribute to ARR and Quality Framework Integration initiatives Drive end-to-end process assessment, development, implementation, and integration Develop and maintain training and qualification materials within the GxP QM framework Perform requirement comparison, assessment, and integration across the QM System Participate in content management and qualification transformation initiatives (e.g., Aris CCL) Align business requirements, regulatory expectations, and QM processes Contribute to changes, CAPAs, inspections, investigations, and regulatory requests Drive project activities: timelines, deliverables, process design, training strategies, implementation, maintenance Manage change management, risk management, issue resolution, and process analysis activities Apply First-Time-Right principles to deliverables and outputs Provide project updates on progress, risks, and resolutions to owners/management Advance data-centric content and qualification management initiatives Collaborate with Therapeutic Areas, Clinical Development, Medical Safety, Regulatory Affairs, and R