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 lifecycle managemen
📌 Product Owner (España)
🏢 Astek
📍 España