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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