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

Job Description
The Position Reporting 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. Responsibilities
- Oversee inbound logistics and serialization data flow from manufacturing sites to Organon’s third‑party logistics (3PL) provider, ensuring EPCIS compliance ahead of product receipt
- Gather and document serialization requirements for new markets
- Execute and/or participate in project teams in design, build, and deployment activities
- Contribute to project impact assessment and scoping
- Act as a key contributor to new product launch initiatives by providing serialization expertise and supporting operational execution across impacted markets
- Liaison for Organon’s 3PL provider, reviewing and monitoring customer exceptions to ensure timely resolution and service compliance
- Collaborate with 3PL partner to maintain operational compliance, drive process improvements, and ensure adherence to customer and company requirements
- Utilize 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 integrity
- Contribute as a key team member in onboarding Contract Manufacturing Organizations (CMOs), supporting cross‑functional coordination to ensure alignment with quality, compliance, and operational requirements
- Process xml messages via the Advanced Track & Trace Cockpit
- Utilized the Integration Control Hub (ICH) to monitor and reprocess message flows, ensuring accurate data exchange and timely resolution of errors
- Create shipping and receiving events
- Write standard operating procedures and work‑step instructions
- Collaborate with Business Technology (BT) to support serialization activities, ensuring system accuracy, data integrity, and compliance with traceability requirements
- Serve as a resource for team members, providing guidance on processes and supporting questions related to daily activities
- Actively search for process efficiencies in the team
- Act as backup support for team members during absences, covering Master Data, reporting, and daily business activities to ensure continuity and accuracy Required Education, Experience & Skills
- Minimum 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 requirements
- Strong knowledge of Pharmaceutical Serialization, GS1 Standards and related technologies (EPCIS)
- Knowledge of Pharmaceutical Track and Trace regulatory reporting requirements
- Knowledge in GS1 standards (GTIN, SGTIN, GLN, SGLN, SSCC, GCP)
- Business process knowledge on pharmaceutical products packaging, aggregation, barcode printing and verification
- Good experience of working with SAP ATTP integration with SAP ECC, packaging line management solution and SAP ICH
- Demonstrated 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 & Skills
- B.
S. in Business, Supply Chain, Engineering or other technical degree.
- Understanding of GxP environments
- Demonstrated project management experience. Secondary Language(s)

Job Description
Le poste Relevant 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. Responsabilités
- Superviser 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.
- Agir à titre de contributeur(trice) clé aux initiatives de lancement de nouveaux produits en fournissant une expertise en sérialisation et en soutenant l’exécution opérationnelle dans les marchés concerné