Required Experience
8+ years of experience in Digital Manufacturing, Serialization, MES, Supply Chain Systems or Track & Trace solutions.
Proven experience managing enterprise applications in regulated industries.
Experience with pharmaceutical serialization regulations and traceability processes.
Experience owning business-critical platforms in production settings.
Proven delivery experience managing complex cross-functional initiatives.
Experience managing software vendors and external service providers.
Required Functional & Technical Skills
Strong understanding of pharmaceutical serialization and traceability processes across manufacturing, distribution, CMOs, affiliates and regulatory reporting.
Solid understanding of serialization architectures and data flows across L1-L5 serialization layers.
Experience with Antares serialization solutions such as F2D2, Track4, Sentry or equivalent platforms.
Experience working with SaaS and hybrid application landscapes.
Strong understanding of serial number lifecycle management, aggregation, commissioning, decommissioning, shipment and regulatory reporting processes.
Knowledge of global serialization regulations such as EMVS, DSCSA and equivalent market regulations.
Understanding of business interfaces and data exchanges between serialization platforms, ERP systems, CMOs, logistics providers, affiliates and health authorities.
Familiarity with APIs, file-based exchanges and integration concepts from a functional and data exchange perspective, without requiring ownership of technical integration components.
Experience with computerized system validation and GxP-regulated environments.
Understanding of data integrity, audit trail and compliance requirements.
Leadership Competencies
Robust ownership mindset and accountability for business outcomes.
Excellent stakeholder management and communication ski