Ensure the deviation process meets Industry and Immunomedics expectations and requirements. Drives continuous improvement and enhancement efforts with regards to the management of Deviations to ensure an efficient yet Compliant process is maintained. Initiates, Reviews and Approves Deviations, OOSs, CAPAs, Quality Events to ensure adequate levels of documentation are adequate and compliant to existing procedures. Provides appropriate feedback as required. Performs CAPA effectiveness checks as required. Supports the coordination of activities associated with event resolution and CAPAs with a focus on organizing and attending cross-functional meetings to lead/facilitate investigations and to provide updates on discrepancy investigations; publish meeting minutes and action items from meetings; provide support to the investigation process and follow-up to ensure timely deviation closure. Initiates Escalation activities as required. Participate in escalation meetings as required. Performs trending analysis of deviations, CAPAs, OOS as required. Supports APQR program with regards to providing analysis for deviations and CAPAs. Supports the preparation and presentation of trend reports for Quality Management Reviews. Implements and ensures adherence of appropriate regulations and Immunomedics quality standards.