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.
