Serialization Program Lead / Serialization Operations SMEs

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.