Support compliance documentation activities related to computer systems, including review coordination, evidence collection, document quality checks, and maintenance of controlled documentation.
The Sr Manager is accountable for ensuring regulatory compliance, driving operational excellence, and enabling strategic transformation of literature review processes, including screening, quality management, search strategy governance, systems, and ancillary operations.
Amgen is seeking a Senior Associate specializing in Commissioning & Qualification (C&Q) to join the Engineering C&Q Center of Excellence (CoE). In this role, you will support the preparation, coordination, and delivery of commissioning and qualification lifecycle documentation supporting engineering projects and GMP manufacturing systems across Amgen operations.
Support execution of core data management activities across the study lifecycle, including database build, edit check testing, lab and coding setup, data cleaning, query management, reconciliation, and lock preparation.
The MDR Lead partners closely with cross functional teams to deliver high-quality, decision-ready clinical data in support of Amgen’s development strategy.
AVP will lead Amgen’s Clinical Data Management function within GDO, ensuring the highest quality of clinical data collection, processing, and analysis to support regulatory submissions and clinical development programs.
GCP Subject Matter Expert, Provide independent and objective quality advice in support of clinical trial activities and in line with current standard methodology. Experience in Quality Management, Quality Assurance. pharmaceuticals
Senior Manager QC Microbiology is responsible for leading and managing the Micro and Environmental Monitoring teams. This role involves setting goals, managing performance, and providing clear direction in line with company goals, with safety as the foundation of all activities.