Serialization Program Lead / Serialization Operations SMEs

Remote • Posted 13 hours ago • Updated 13 hours ago
Contract Independent
Contract W2
Remote
Depends on Experience
Fitment

Dice Job Match Score™

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Job Details

Skills

  • CMO
  • DSCSA
  • EU
  • FMD
  • ATTP

Summary

Job Description :

  • Lead end-to-end serialization program execution across multiple manufacturing sites and Contract Manufacturing Organizations (CMOs).
  • Manage serialization and aggregation deployments for pharmaceutical packaging lines.
  • Ensure compliance with global regulatory requirements, including DSCSA, EU FMD, Brazil ANVISA, Russia CRPT, and other country-specific mandates.
  • Coordinate with business, supply chain, quality, regulatory affairs, manufacturing, and IT teams to define serialization strategies and roadmaps.
  • Oversee implementation and support of serialization platforms such as SAP ATTP, SAP Information Collaboration Hub (ICH), SAP Event Management, TraceLink, Systech, or similar solutions.
  • Drive project planning, risk management, resource allocation, budgeting, and stakeholder communications.
  • Support onboarding and integration of CMOs, distributors, and packaging partners into serialization ecosystems.
  • Monitor serialization operations, exception management, data quality, and compliance reporting.
  • Lead validation activities, including IQ/OQ/PQ, CSV documentation, and audit readiness.
  • Manage vendor relationships and coordinate with third-party solution providers.
  • Develop governance models, SOPs, and operational procedures for serialization processes.
  • Provide leadership for issue resolution, root cause analysis, and continuous process improvement initiatives.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 90942582
  • Position Id: 9001419
  • Posted 13 hours ago
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