Senior Specialist – Serialization Operations Americas/Spécialiste principal(e) – Opérations de Sérialisation, Amériques

Organon • Jersey City, NJ

4d • Remote

About 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.

Requirements

• 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.

Nice To Haves

• B.S. in Business, Supply Chain, Engineering or other technical degree.
• Understanding of GxP environments
• Demonstrated project management experience.

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

Benefits

• a retirement savings plan
• paid vacation and holiday time
• paid caregiver/parental and medical leave
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior