At ASTEK, we are looking for a Product Owner – Serialization & Traceability to join a project within the pharmaceutical sector, in the Digital Manufacturing & Supply area, focused on the management and evolution of the Serialization & Traceability ecosystem. ? What will your mission be? You will be responsible for the end-to-end management and evolution of the Serialization & Traceability ecosystem, ensuring business continuity, regulatory compliance and operational performance of GxP-regulated systems while driving strategic transformation. * Define the Serialization & Traceability strategy and roadmap and manage the lifecycle of platforms such as F2D2, Track4, TraceLink and Sentry. * Ensure operational stability, business continuity and regulatory compliance, including incident, change and release management, KPIs and SLAs. * Ensure compliance with GxP, Computerized System Validation, audit and regulatory inspection requirements. * Manage vendors, system integrators, CMOs and other stakeholders, collaborating with Architecture, Cybersecurity, Infrastructure and Integration teams.
* Drive standardization and continuous improvement of serialization and traceability processes. * Contribute strategically to the F2D2 Separation Program, supporting the definition and evolution of the future independent serialization platform. ✅ Who are you? * You have 6 years of experience in Digital Manufacturing, Serialization, MES, Supply Chain Systems or Track & Trace solutions. * You have experience managing business-critical applications in production within regulated industries, as well as complex initiatives and external vendors. * You have strong knowledge of pharmaceutical serialization and traceability, including L1-L5 architectures and data flows. * You have experience with Antares serialization solutions such as F2D2, Track4, Sentry or equivalent platforms, as well as SaaS and hybrid application landscapes. * You understand serialization processes including serial number li
📌 Product Owner (España)
🏢 Astek
📍 España