Serialization Product Owner - Remote - INDIA

Contexte de la mission:

Location: Anywhere from India - REMOTE
Rate: 188 EUR / Day
Start: ASAP
Duration: 6 months renewable

Act as Product Owner for the Serialization ecosystem, defining priorities, roadmap and product direction across F2D2, Track4, TraceLink and Sentry.

Ensure stable, reliable and compliant operation of serialization applications with no business disruption across the manufacturing and supply network.

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 F2D2 separation / transformation project, supporting the definition of the future-state Opella solution, TSA exit, target capabilities, business continuity and roadmap alignment.

Govern vendor performance, support model, releases, enhancements, incidents, problem management and lifecycle activities with Antares, TraceLink and other relevant partners. Ensure GxP compliance, validation readiness, audit readiness, data integrity and regulatory reporting continuity across the serialization landscape.

Coordinate with the Serialization Functional Expert and Serialization Project Manager in a dotted-line / matrix model to secure delivery of new functionalities, regulatory changes, releases and lifecycle activities.

Collaborate with Enterprise Architecture, Cybersecurity, Infrastructure and Integration teams on major initiatives, while technical architecture ownership remains with Enterprise Architecture.

Serialization product roadmap and prioritization backlog maintained and aligned with business, compliance and transformation priorities.

Documented product decisions, business requirements, functional priorities and roadmap inputs for F2D2, Track4, TraceLink and Sentry. F2D2 separation / transformation support, including contribution to target-state definition, TSA exit planning, business continuity requirements and product readiness activities.

Validated and prioritized demand pipeline for enhancements, bug fixes, patches, regulatory changes and releases. Vendor governance follow-up, including service performance, issue escalation, delivery tracking and roadmap alignment.

Operational service oversight, including follow-up of incidents, recurring issues, change requests, releases and lifecycle risks. Compliance and validation inputs for GxP activities, audit readiness, data integrity and regulatory reporting continuity. Regular status updates to Digital Manufacturing leadership and key stakeholders on product risks, decisions, priorities and delivery progress.


Objectifs et livrables:

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 environments.
- 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.
- 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.

Positioning note: This role is intended to cover strategic product ownership and functional lifecycle accountability for the Serialization ecosystem. Enterprise architecture, technical standards and integration architecture decisions remain under Enterprise Architect ownership, with the Product Owner contributing business and functional direction.

Informations de la mission :

• Début de mission : 24/08/2026
• Durée : 6 mois
• Date de publication : 17/08/2026
• Date limite de candidature : 31/08/2026