Supports the R&D Quality (RDQ) Compliance Managers in the following areas:
Input of audit responses into QMS
Input of site inspection data into the Inspection Management System
Working with deviation owners to ensure the timely development and closure of CAPAs. Ensuring deviation owners are submitting objective evidence within agreed timelines, where applicable
Ensuring the timely preparation and submission of documentation to the Potentially Reportable Serious Breach committee
Collaboration with the Clinical Study Team, as directed by the RDQ Compliance Manager, to facilitate communication
Prepare weekly metric reports for the General Medicine team, including, but not limited to, open deviations, CAPAs, serious breaches, audit and inspection findings. Highlighting overdue items and supporting the RDQ compliance managers to ensure timely closure.
Working with the RDQ Compliance Manager and data quality analytics team to assess the effectiveness of metric reports and optimize as required
Facilitate General Medicine team meetings, including agenda and presentation preparation. Maintain a Decision & Action log, follow up with action owners until resolution. Management of a Q&A log.
Support inspection readiness activities under the supervision of the RDQ Compliance Manager
Quality oversight of small clinical programs under the guidance of the RDQ Compliance Manager
Demonstrated ability to leverage artificial intelligence (AI) tools and technologies to streamline workflows, drive process automation, and support data-driven decision-making. Must be adept at identifying opportunities to apply AI for operational efficiency and continuous improvement initiatives.
Support the RDQ Compliance Manager to develop lessons learned and best practices documentation
Collaborate with other Amgen R&D Quality functions as required
Maintenance of General Medicine SharePoint site and Teams channels
