Global Serialization Operations Specialist

Career Category

Engineering

Job Description

Delivers compliant, timely and inspection-ready global serialization operations across the US, EU, MEA and JAPAC.
The role operates in a structured, multi-region shift model, providing run-with-the-sun coverage through clear handovers and coordinated support across time zones. It combines hands-on exception management, EU FMD execution, PID activities, US customer setup and technical-services support.
Working closely with regional process owners, Quality, affiliates, sites, LSPs and technology partners, the Specialist ensures reliable end-to-end execution and operational continuity.

Key responsibilities

• Manage day-to-day global serialization exceptions across US, EU, MEA and JAPAC, ensuring timely triage, coordination, escalation, follow-up and closure.
• Execute EU FMD operational processes in accordance with approved procedures, work instructions and training requirements.
• Monitor EU FMD reporting and alerts, including investigation coordination, reprocessing, stakeholder communication and timely case closure.
• Execute and maintain Product Identifier Database (PID) activities, ensuring accurate, controlled and timely product-identifier data.
• Support US customer setup activities for DSCSA serialization and traceability requirements.
• Provide technical-services support, including change-control coordination and technical writing for controlled procedures, work instructions and process documentation.
• Maintain inspection readiness through complete case documentation, process evidence, training records, KPI reporting and clear audit trails.
• Provide support within a structured global shift model, ensuring effective handovers, prioritization of critical events and continuity of operations.
• Monitor service performance, case ageing, alert-resolution timelines, right-first-time execution and recurring root causes.
• Partner with regional process owners, Quality, affiliates, sites, LSPs and technical teams to resolve complex operational issues.
• Identify process gaps and recurring deviations; contribute to corrective actions, global playbooks, knowledge management and process standardization.
• Support serialization inspections, audits, recalls and significant supply events through prompt, accurate and compliant operational coordination.
• Contribute operational expertise to S/4HANA, ICH and future platform initiatives, including process design, testing and deployment readiness.

Key outcomes

• Timely and compliant resolution of serialization exceptions across US, EU, MEA and JAPAC.
• Reliable execution of EU FMD reporting, alert monitoring and reprocessing activities.
• Accurate and controlled PID maintenance and effective US DSCSA customer setup support.
• Sustained inspection readiness with clear, retrievable evidence of process execution.
• Reliable shift coverage and seamless handover between global operations teams.
• Reduced recurrence of operational issues through root-cause management, standardization and continuous improvement.
• Strong operational input into the future S/4HANA and ICH platform model.

Qualifications – Global Serialization Operations Specialist (AIN)

• Bachelor’s degree in Supply Chain, Life Sciences, Pharmacy, Engineering, Information Systems or a related discipline.
• 5–9 years of experience in pharmaceutical supply chain, serialization/traceability, quality operations, regulatory reporting or technical services.
• Experience with serialized-product processes, including exception management, data investigation, reconciliation and controlled documentation.
• Knowledge of EU FMD; exposure to US DSCSA, MEA or JAPAC traceability requirements is preferred.
• Familiarity with SAP ATTP, TraceLink, SAP ICH, EPCIS, GS1 standards, Product Identifier Data and/or case-management tools is preferred.
• Understanding of GxP principles, data integrity, change control, deviation/investigation management and inspection readiness.
• Able to interpret operational data, identify trends and support root-cause analysis and corrective actions.
• Strong written English and clear stakeholder communication across global teams, sites, affiliates, LSPs and Quality.
• Comfortable working in a defined shift structure, including disciplined handovers and time-sensitive escalation of critical events.
• Demonstrated attention to detail, ownership, prioritization and ability to work independently in a controlled, high-compliance environment.
• Technical writing experience for SOPs, work instructions or process documentation is preferred.

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