- 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 environments.
- Proven delivery experience managing complex cross-functional initiatives.
- Experience managing software vendors and external service providers.
Required Functional & Technical Skills
- Robust understanding of pharmaceutical serialization and traceability processes across manufacturing, distribution, CMOs, affiliates and regulatory reporting.
- Strong 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
- Strong ownership mindset and accountability for business outcomes.
- Excellent stakeholder management and communication skills.
- Ability to influence across global and matrix organizations.
- Strong analytical and problem-solving capabilities.
- Ability to operate effectively in complex, highly regulated environments.
- Customer-focused and results-oriented approach.
- Ability to balance strategic direction with operational execution.