Senior Serialization Operations Lead – Americas

Organon

United States

On-site

USD 95,000 - 130,000

Full time

4 days ago

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Job summary

Organon seeks a Serialization Senior Specialist to act as SME for serialization across the Americas. You will oversee data flow from sites to 3PL, ensure EPCIS compliance, document market requirements, and drive project design, build, and deployment.

The role requires 4+ years in supply chain or regulatory areas and 2+ years in serialization, with strong SAP/EPCIS knowledge. The position is based in the United States (EST) and involves collaboration with 3PL partners, CMOs, and Quality to

Qualifications

Minimum of 4 years in supply chain, operations, logistics, or regulatory areas.
Minimum of 2 years with serialization processes and data requirements.
Strong knowledge of pharmaceutical serialization, GS1 standards and EPCIS.
Experience with SAP ATTP integration and SAP ICH is preferred.
Excellent English communication and cross-functional collaboration skills.
Based in US time zone (EST) and able to coordinate globally.

Responsibilities

Oversee serialization data flow from manufacturing to 3PL and ensure EPCIS compliance.
Gather and document serialization requirements for new markets.
Lead or participate in project teams for design, build, and deployment activities.
Collaborate with 3PLs to ensure operational compliance and process improvement.
Utilize VRS and ICH tools to validate products and resolve issues with Quality.
Support onboarding of CMOs and ensure alignment with quality and regulatory needs.
Create SOPs and work instructions; liaise with BT for data integrity and traceability.
Act as a resource for the team and seek continuous process improvements.