Amgen seeks a Global Serialization Operations Specialist to manage pharmaceutical serialization compliance and traceability operations across multiple regions in a structured shift model. The role requires exception management, EU FMD execution, product identifier data maintenance, and coordination with quality, sites, and logistics partners to ensure inspection readiness.
Responsibilities
Manage global serialization exceptions across US, EU, MEA, and JAPAC with triage, coordination, and closure
Execute EU FMD operational processes, monitor alerts, and coordinate investigations and reprocessing activities
Maintain Product Identifier Database accuracy and support US customer setup for DSCSA requirements
Ensure inspection readiness through case documentation, process evidence, training records, and audit trails
Partner with regional process owners, Quality, and logistics partners to resolve complex operational issues and identify process improvements
Requirements
Bachelor's degree in Supply Chain, Life Sciences, Pharmacy, Engineering, or related field
5–9 years pharmaceutical supply chain, serialization, quality operations, or regulatory reporting experience
Hands-on experience with serialized-product exception management, data investigation, and controlled documentation
Knowledge of EU FMD; familiarity with US DSCSA, MEA, or JAPAC requirements preferred
Understanding of GxP principles, data integrity, change control, and inspection-readiness requirements
Strong written English; ability to communicate with global teams, sites, and quality stakeholders
Ability to work in structured shift model with disciplined handovers and time-sensitive escalation
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