Demo

Supply Chain Manager

Planet Pharma
Bristol, TN Full Time
POSTED ON 4/22/2025
AVAILABLE BEFORE 5/21/2025

We are seeking a DSCSA Compliance Manager with deep expertise in serialization, traceability, and pharma supply chain compliance. This individual will play a key role in ensuring alignment with the Drug Supply Chain Security Act (DSCSA) and related global regulations (FMD, etc.) through the implementation and oversight of serialization systems and data integrity practices.


Key Responsibilities:

  • Lead and support serialization and traceability initiatives across L3–L5 packaging systems.
  • Ensure compliance with DSCSA and other global serialization regulations through system configuration, validation, and maintenance.
  • Maintain traceability across the full supply chain, from ERP to MES to packaging lines.
  • Drive data integrity initiatives and resolve serialization-related discrepancies.
  • Review and support validation documentation (CSV, IQ/OQ/PQ) to meet FDA and international standards.
  • Serve as a liaison between operations, IT, QA, and external vendors.

Required Qualifications:

  • 3 years of experience in serialization, traceability, or DSCSA compliance, preferably within the pharmaceutical industry.
  • Hands-on experience with serialization platforms (SAP ATTP, TraceLink, etc.).
  • Strong understanding of global compliance frameworks (DSCSA, FMD, etc.).
  • Familiarity with data structures used in track-and-trace systems: GTINs, 2D barcodes, serial numbers, etc.
  • Proven experience maintaining compliance and data integrity across interconnected systems (ERP/MES/Line level).


Salary Range $95-105K/yr

Salary : $95,000 - $105,000

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