Senior Associate Quality Compliance

Role: Senior Associate Quality Compliance supporting Amgen’s R&D Quality Management System across all stages of clinical programs. Responsibilities include managing audit responses, site inspection data, deviations, CAPAs, and serious breach documentation; facilitating communication with clinical teams; preparing weekly metrics; supporting inspection readiness; providing quality oversight of small clinical programs; and leveraging AI tools for workflow automation and process improvement. Qualifications: Master’s degree or equivalent experience—minimum 2 years in scientific or healthcare fields; knowledge of Clinical R&D activities, GCP, and regulatory requirements; proficiency in GxP regulations (ICH E6R3, 21 CFR parts); strong communication and attention to detail skills. Preferred: experience in GCP quality compliance, R&D processes, and regulatory submissions. High-Value: supporting clinical development in small to medium programs, with a focus on quality system strengthening, audit and inspection facilitation, and data-driven quality oversight. Collaboration involves working with RDQ Compliance Managers, clinical teams, and data analytics. Work setup: not explicitly specified, but implied to be in a collaborative environment supporting global clinical R&D activities.