Senior Associate Quality Compliance

Job Summary

Supporting the advancement of Amgen's R&D Quality Management System, the full-time remote Senior Associate Quality Compliance will manage quality support for clinical development programs, including audit responses, deviation management, and metric reporting.

Key responsibilities

• Input audit responses and site inspection data into relevant systems while ensuring timely closure of corrective actions
• Prepare and present weekly metric reports, highlighting overdue items and collaborating with compliance managers
• Facilitate team meetings and maintain documentation, including decision logs and SharePoint site management

Required qualifications

• Master's degree OR Bachelor's degree with 2 years of relevant experience OR Associate's degree with 6 years of relevant experience OR High school diploma with 8 years of relevant experience
• Understanding of Clinical R&D activities and Global Regulations
• Knowledge of Good Clinical Practice (GCP) and related regulatory requirements
• Proficiency in Microsoft Office
• Experience with audit and inspection management processes