Senior Specialist – Serialization Operations Americas/Spécialiste Principal(E) – Opérations De Sérialisation, Amériques

Secondary Language(s)

Job Description
Le posteRelevant du/de la Responsable de la sérialisation au sein du Centre d'excellence mondial en sérialisation, la personne retenue agira à titre de principal point de contact et d'expert(e) de la matière (SME) pour le soutien à la sérialisation et l'escalade des incidents au sein de la région des Amériques.

Job Description
The PositionReporting into the Serialization Lead in the Global Serialization Centre of Excellence team, the successful candidate will act as a key point of contact and SME for serialization support and issue escalation within the Americas region.
ResponsibilitiesOversee inbound logistics and serialization data flow from manufacturing sites to Organon's third-party logistics (3PL) provider, ensuring EPCIS compliance ahead of product receiptGather and document serialization requirements for new marketsExecute and/or participate in project teams in design, build, and deployment activitiesContribute to project impact assessment and scopingAct as a key contributor to new product launch initiatives by providing serialization expertise and supporting operational execution across impacted marketsLiaison for Organon's 3PL provider, reviewing and monitoring customer exceptions to ensure timely resolution and service complianceCollaborate with 3PL partner to maintain operational compliance, drive process improvements, and ensure adherence to customer and company requirementsUtilize Verification Router Service (VRS) to assess and validate suspect product, partnering with Quality to investigate issues, determine root cause, and support disposition decisions to ensure compliance and product integrityContribute as a key team member in onboarding Contract Manufacturing Organizations (CMOs), supporting cross-functional coordination to ensure alignment with quality, compliance, and operational requirementsProcess xml messages via the Advanced Track & Trace CockpitUtilized the Integration Control Hub (ICH) to monitor and reprocess message flows, ensuring accurate data exchange and timely resolution of errorsCreate shipping and receiving eventsWrite standard operating procedures and work-step instructionsCollaborate with Business Technology (BT) to support serialization activities, ensuring system accuracy, data integrity, and compliance with traceability requirementsServe as a resource for team members, providing guidance on processes and supporting questions related to daily activitiesActively search for process efficiencies in the teamAct as backup support for team members during absences, covering Master Data, reporting, and daily business activities to ensure continuity and accuracyRequired Education, Experience & SkillsMinimum of 4 years of relevant work experience i.e. Supply Chain Management, Plant Operations, Distribution, Logistics, Regulatory etc.
Minimum of 2 years experience working with Serialization processes and data requirementsStrong knowledge of Pharmaceutical Serialization, GS1 Standards and related technologies (EPCIS)Knowledge of Pharmaceutical Track and Trace regulatory reporting requirementsKnowledge in GS1 standards (GTIN, SGTIN, GLN, SGLN, SSCC, GCP)Business process knowledge on pharmaceutical products packaging, aggregation, barcode printing and verificationGood experience of working with SAP ATTP integration with SAP ECC, packaging line management solution and SAP ICHDemonstrated ability to align, lead and drive change activities across global and/or cross-functional teams towards a common goal.
A strong appreciation that the best results come from the combined efforts of diverse teams and shared perspectives.
Strong oral and written communication skills in English with a proven ability to organize business process and complex information in a concise and compelling manner.
Lean/continuous improvement mindset.
The role will be based in the US time zone, EST.
Preferred Education, Experience & SkillsB.
S.
in Business, Supply Chain, Engineering or other technical degree.
Understanding of GxP environmentsDemonstrated project management experience.
Secondary Language(s)

Job Description
Le posteRelevant du/de la Responsable de la sérialisation au sein du Centre d'excellence mondial en sérialisation, la personne retenue agira à titre de principal point de contact et d'expert(e) de la matière (SME) pour le soutien à la sérialisation et l'escalade des incidents au sein de la région des Amériques.
ResponsabilitésSuperviser la logistique entrante et le flux de données de sérialisation entre les sites de fabrication et le fournisseur de services logistiques tiers (3PL) d'Organon, en veillant à la conformité EPCIS avant la réception des produits.
Recueillir et documenter les exigences de sérialisation pour les nouveaux marchés.
Exécuter et/ou participer aux équipes de projet dans le cadre des activités de conception, de configuration, de mise en œuvre et de déploiement.
Contribuer à l'évaluation des impacts et à la définition de la portée des projets.
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