Position: Pharma Serialization Expert
Location: 100% Remote
Duration: Long Term
Job Description:
Position Overview
We are seeking a Pharmaceutical Serialization Expert to lead and support serialization and track-and-trace initiatives across global pharmaceutical supply chains. The role will focus on ensuring compliance with global regulations such as DSCSA (U.S.), EU FMD, and other global serialization mandates, while supporting system implementation, data integration, and operational readiness across manufacturing and distribution partners.
The ideal candidate will possess deep expertise in serialization architecture, regulatory compliance, supply chain integration, and pharmaceutical manufacturing systems.
Key Responsibilities
Serialization Program Leadership
Lead serialization and track-and-trace initiatives across manufacturing, packaging, and distribution networks.
Support global compliance with regulations such as DSCSA, EU FMD, ANVISA, SFDA, and other regional mandates.
Collaborate with regulatory, quality, supply chain, and IT teams to ensure compliance readiness.
System Implementation & Integration
Implement and manage serialization platforms such as:
SAP ATTP
TraceLink
SAP ICH
Arvato
Systech
Support integration with enterprise systems including:
ERP systems (SAP)
Manufacturing Execution Systems (MES)
Warehouse Management Systems (WMS)
Packaging line controllers
Data & Reporting
Ensure accurate product serialization data exchange across partners.
Manage master data for serialized products including GTIN, batch data, and serial numbers.
Monitor reporting and compliance data submissions to government repositories.
Packaging & Manufacturing Support
Support serialization implementation at packaging lines.
Work with equipment vendors for:
Line integration
Vision systems
Labeling and aggregation
Ensure correct aggregation (unit, case, pallet) processes.
Compliance & Validation
Ensure systems meet GxP validation requirements.
Support:
Computer System Validation (CSV)
IQ/OQ/PQ documentation
Audit readiness
Maintain serialization documentation and SOPs.
Partner & Supply Chain Collaboration
Coordinate with CMOs, wholesalers, and distributors.
Ensure smooth data exchange and EPCIS compliance across trading partners.
Support onboarding of new supply chain partners.
Required Qualifications
Education
Bachelor's or Master's degree in:
Supply Chain
Pharmaceutical Sciences
Computer Science
Engineering
Life Sciences
Experience
5 10+ years in pharmaceutical serialization or track-and-trace programs.
Experience implementing serialization solutions in pharma manufacturing environments.
Strong knowledge of global serialization regulations.
Best Regards,
Ashok Kumar
Sr. Talent Acquisition Specialist
Email:
Web: ;br /> 4229 Lafayette Center Dr, Suite 1880, Chantilly, VA 20151
Never miss an opportunity! Create an alert based on the job you applied for.
