• Lead investigations and CAPA management for labeling-related deviations, driving root-cause analysis, trend identification, and cross-functional remediation • Oversee E2E labeling process updates, escalation management, and process-to-system alignment • Serve as CAPA Owner for process improvements and ensure clear communication of changes to stakeholders • Support business partners and Safety Data Exchange Agreement obligations, ensuring roles, responsibilities, and clear process management are established to comply with contractual terms and conditions • Act as Business Contact for Veeva RIMS, TrackWise, QDocs, and related systems • Oversee system enhancements, issue resolution, and workflow maintenance • Ensure effective process-to-system handoffs to support compliant and efficient labeling operations • Lead preparation and coordination for audits and inspections, ensuring a 'permanently inspection-ready' environment • Maintain the Global Labeling Audit & Inspection Storyboard and develop supporting process flow maps • Produce required system outputs and documentation, and support key SMEs and stakeholders during inspection interviews • Serve as Veeva COP (Community of Practice) process expert and drive continuous improvement initiatives • Ensure consistency of E2E labeling process handoffs across functions and regions • Partner with Regulatory, Pharmacovigilance, Quality, and Manufacturing to address systemic issues and strengthen interdependencies • Develop and deliver Global Labeling training materials • Contribute Global Labeling perspective to regulatory intelligence reviews and process impact assessments