Global Serialization Operations Specialist
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Job Description
Structured overview of role & requirementsAbout This Role
Manage day-to-day global serialization exceptions across US, EU, MEA and JAPAC ensuring timely triage, escalation, and closure.
Execute and maintain EU FMD operational processes and PID activities meeting compliance and inspection readiness requirements.
Support US DSCSA customer setup, provide technical services including change control and documentation, and ensure reliable shift coverage with coordinated global handovers.
Minimum Requirements
Bachelor’s degree in Supply Chain, Life Sciences, Pharmacy, Engineering, Information Systems or related discipline.
5–9 years experience in pharmaceutical supply chain, serialization/traceability, quality operations, regulatory reporting, or technical services.
Knowledge of EU FMD is mandatory; exposure to US DSCSA, MEA or JAPAC traceability is preferred.
Comfortable working in a structured global shift model with disciplined handovers and time-sensitive escalation of critical events.
Ideal Candidate Profile
Experienced in serialized-product exception management, data investigation, reconciliation, and controlled documentation in a high-compliance pharmaceutical environment.
Strong operational understanding of global serialization processes with ability to interpret data, identify trends, and support root-cause analysis and continuous improvement.
Effective communicator across global and cross-functional teams with demonstrated ownership, attention to detail, and capability to independently manage technical writing and process documentation.
