Senior Associate Quality Compliance

Senior Associate Quality Compliance position supporting Amgen's R&D Quality Management System and clinical development programs. Responsibilities include managing audit responses, inspection data, deviations, and CAPAs while preparing compliance reports and facilitating team meetings across therapeutic programs.

Responsibilities

• Input audit responses and site inspection data into quality management and inspection systems
• Support deviation owners and coordinate timely CAPA development, closure, and documentation submission
• Prepare weekly compliance metric reports for clinical teams highlighting overdue items and findings
• Facilitate team meetings including agenda preparation, decision tracking, and action item follow-up
• Support inspection readiness activities and provide quality oversight of clinical programs under manager guidance

Requirements

• Master's degree, or Bachelor's degree with 2+ years scientific/healthcare experience
• Knowledge of Good Clinical Practice (GCP) requirements and international regulatory standards
• Understanding of clinical R&D activities and global regulatory procedures
• Familiarity with R&D processes, inspection management, and regulatory submission procedures
• Proficiency in Microsoft Office and ability to work under pressure with strong attention to detail
• Excellent written and verbal communication skills with strong interpersonal abilities
• Experience with AI tools and technologies for workflow automation and process improvement