GCP Auditor - Global R&D Audit

Role: GCP Auditor within Amgen’s R&D Quality Audit Team, responsible for planning and executing global GCP compliance audits across clinical trials and supporting regulatory inspections. Responsibilities include conducting routine and complex audits, identifying compliance risks, hosting regulatory authority inspections, and contributing to process improvements and documentation. Qualifications: Doctorate or Master’s with 2+ years, Bachelor’s with 4+ years, Associate’s with 8+ years, or high school with 10+ years in scientific, medical, or pharmacy fields. Preferred: postgraduate qualifications, extensive international GCP audit experience, data analytics skills, strong communication. High-Value: focus on clinical development, GCP compliance, international audits, regulatory interactions, with up to 40% travel. Work setup: global role with travel; location flexible within the U.S.