CDISpain
Serialization Product Owner
Hybride
Project Details
- Location: Europe (CET)
- Work mode: Full remote with sporadic on-site travel
- Start date: ASAP
- Duration: 6 months
- Extension possibility: Yes
- Language(s): English
Project Summary
We are looking for a Product Owner for our Serialization and Traceability ecosystem within our Digital Manufacturing and Supply organization. You will own the lifecycle, roadmap and compliance of the platforms supporting site-level serialization and aggregation, global traceability and regulatory reporting, B2B connectivity with CMOs, and serialization alert and exception management.
Two priorities: keep these GxP-regulated, business-critical services running without disruption across manufacturing sites, CMOs and affiliates, and contribute to a platform modernization program aimed at moving one of the core serialization applications to a standard version hosted in our cloud environment.
Main Responsibilities & Key Activities
- Act as Product Owner for the Serialization ecosystem, defining priorities, roadmap and product direction across all serialization and traceability platforms.
- Own the multi-year roadmap and prioritize enhancements, regulatory requirements, technical debt reduction and transformation initiatives.
- Ensure stable, reliable and compliant operation of serialization applications with no business disruption across the manufacturing and supply network.
- Govern incident, problem, change and release management activities, monitor service performance, KPIs and vendor SLAs, and lead major incident resolution and business continuity activities.
- Partner with business stakeholders, Serialization Operations, Quality, Regulatory Affairs, manufacturing sites, CMOs, affiliates and Digital teams to translate business needs and regulatory requirements into product priorities.
- Contribute strategically to the platform modernization program: future-state solution definition, target capabilities, business continuity and roadmap alignment.
- Govern vendor performance, support model, releases, enhancements, incidents, problem management and lifecycle activities with serialization platform vendors and B2B connectivity providers.
- Ensure GxP compliance, computerized system validation, audit readiness, data integrity and regulatory reporting continuity across the serialization landscape.
- Coordinate with a Serialization Functional Expert and a Serialization Project Manager in a dotted-line matrix model (2 people plus vendors) to secure delivery of new functionalities, regulatory changes, releases and lifecycle activities.
- Collaborate with Enterprise Architecture, Cybersecurity, Infrastructure and Integration teams on major initiatives. Technical architecture ownership remains with Enterprise Architecture.
- Provide regular status updates to Digital Manufacturing leadership and key stakeholders on product risks, decisions, priorities and delivery progress.
Experience Required
- 5+ 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.
- Experience with enterprise serialization platforms covering site-level serialization, L4 regulatory reporting, CMO connectivity and alert management.
- Experience working with SaaS and hybrid application landscapes.
- Experience with computerized system validation and GxP-regulated environments.
- Strong 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 to L5 serialization layers.
- 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 ownership of technical integration components.
- Understanding of data integrity, audit trail and compliance requirements.
Informations de la mission :
- Location: Europe (CET)
- Work mode: Full remote with sporadic on-site travel
- Start date: ASAP
- Duration: 6 months
- Extension possibility: Yes
- Language(s): English
Project Summary
We are looking for a Product Owner for our Serialization and Traceability ecosystem within our Digital Manufacturing and Supply organization. You will own the lifecycle, roadmap and compliance of the platforms supporting site-level serialization and aggregation, global traceability and regulatory reporting, B2B connectivity with CMOs, and serialization alert and exception management.
Two priorities: keep these GxP-regulated, business-critical services running without disruption across manufacturing sites, CMOs and affiliates, and contribute to a platform modernization program aimed at moving one of the core serialization applications to a standard version hosted in our cloud environment.
Main Responsibilities & Key Activities
- Act as Product Owner for the Serialization ecosystem, defining priorities, roadmap and product direction across all serialization and traceability platforms.
- Own the multi-year roadmap and prioritize enhancements, regulatory requirements, technical debt reduction and transformation initiatives.
- Ensure stable, reliable and compliant operation of serialization applications with no business disruption across the manufacturing and supply network.
- Govern incident, problem, change and release management activities, monitor service performance, KPIs and vendor SLAs, and lead major incident resolution and business continuity activities.
- Partner with business stakeholders, Serialization Operations, Quality, Regulatory Affairs, manufacturing sites, CMOs, affiliates and Digital teams to translate business needs and regulatory requirements into product priorities.
- Contribute strategically to the platform modernization program: future-state solution definition, target capabilities, business continuity and roadmap alignment.
- Govern vendor performance, support model, releases, enhancements, incidents, problem management and lifecycle activities with serialization platform vendors and B2B connectivity providers.
- Ensure GxP compliance, computerized system validation, audit readiness, data integrity and regulatory reporting continuity across the serialization landscape.
- Coordinate with a Serialization Functional Expert and a Serialization Project Manager in a dotted-line matrix model (2 people plus vendors) to secure delivery of new functionalities, regulatory changes, releases and lifecycle activities.
- Collaborate with Enterprise Architecture, Cybersecurity, Infrastructure and Integration teams on major initiatives. Technical architecture ownership remains with Enterprise Architecture.
- Provide regular status updates to Digital Manufacturing leadership and key stakeholders on product risks, decisions, priorities and delivery progress.
Experience Required
- 5+ 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.
- Experience with enterprise serialization platforms covering site-level serialization, L4 regulatory reporting, CMO connectivity and alert management.
- Experience working with SaaS and hybrid application landscapes.
- Experience with computerized system validation and GxP-regulated environments.
- Strong 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 to L5 serialization layers.
- 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 ownership of technical integration components.
- Understanding of data integrity, audit trail and compliance requirements.
Informations de la mission :
- Début de mission : 18/08/2026
- Durée : 6 mois
- Date de publication : 18/08/2026
- Date limite de candidature : 21/08/2026
Compétences recherchées
Serialization (Indispensable)Traceability (Indispensable)GxP (Indispensable)MES (Indispensable)SaaS (Indispensable)APIs (Indispensable)Cloud (Indispensable)L1-L5 (Indispensable)L4 regulatory reporting (Indispensable)CMO connectivity (Indispensable)B2B connectivity (Indispensable)Computerized System Validation (Indispensable)Data integrity (Indispensable)Integration (Indispensable)ERP (Indispensable)
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