Compliance

• Assist in the implementation, monitoring, and continuous improvement of Amgen’s R&D Quality Management System (QMS) and Regional Quality Oversight
• Track, document, and implement quality initiatives ensuring procedures and processes meet regulatory requirements
• Contribute to collection, analysis, and reporting of quality metrics (KPIs, KQIs) to identify trends, risks, and improvement areas
• Provide hands-on support to ensure procedural compliance with GCP standards and other regulatory requirements across R&D
• Act as liaison between the Process Quality function and Global Networks to support collaboration and information exchange
• Provide quality oversight primarily for key target sites
• Perform focused readiness checks of clinical trials remote and onsite
• Perform risk assessments to support identification of sites for audits
• Identify data quality indicators/trends, identify areas of weakness/gaps, recommend and implement corrective actions
• Coordinate activities related to site/sponsor inspections and audits including preparation, conduct, close out and response generation

Quality Compliance Manager, GCP

Regulatory Affairs Consultant – CMC