Senior Associate Quality Compliance
Amgen · Remote
QualityRemoteFull-timeCompany career page
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Role summary
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.
What they're looking for
- 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
What you'll be doing
- 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
Privacy & handoff
This role links to Amgen's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.