Product Owner – Serialization & Traceability

Location: Remote,India

Department: Digital Manufacturing & Supply

Reporting To: Digital Product Lead – Manufacturing

Experience: 8+ Years

Role Overview

We are looking for a Product Owner – Serialization & Traceability to own the end-to-end lifecycle, evolution, compliance, and operational performance of the Serialization and Traceability ecosystem.

The role will drive product strategy, roadmap, compliance, service governance, vendor management, and transformation initiatives across pharmaceutical manufacturing, supply chain, CMOs, affiliates, distribution partners, and regulatory stakeholders.

Key Responsibilities

Product Strategy & Roadmap

- Own the Serialization & Traceability product strategy and multi-year roadmap.
- Manage platforms including F2D2, Track4, TraceLink, Sentry and eSASL.
- Prioritize enhancements, regulatory requirements, technical debt, and transformation initiatives.
- Balance business value, compliance, operational stability, and cost efficiency.

Service & Application Ownership

- Ensure reliable, compliant operation of the Serialization ecosystem.
- Govern incident, problem, change, and release management.
- Monitor service KPIs and vendor SLAs.
- Lead major incident resolution and business continuity activities.
- Own application lifecycle and production performance.

Serialization & Compliance

- Ensure compliance with global serialization and traceability regulations.
- Maintain audit readiness and support regulatory inspections.
- Ensure CSV and GxP compliance throughout the application lifecycle.
- Manage serial number lifecycle, aggregation, commissioning, decommissioning, shipment,



and regulatory reporting processes.

Transformation & Product Leadership

- Define the future-state vision for the Serialization platform.
- Support strategic transformation initiatives, including the F2D2 Separation Program.
- Translate business requirements into product roadmaps and delivery priorities.
- Drive harmonization and standardization of serialization processes globally.
- Collaborate with Architecture, Cybersecurity, Infrastructure, Integration, and Manufacturing teams.

Vendor & Stakeholder Management

- Own relationships with strategic vendors such as Antares and TraceLink.
- Drive vendor performance and roadmap alignment.
- Coordinate with system integrators, support providers, CMOs, affiliates, and external stakeholders.
- Influence stakeholders across global and matrix organizations.

Required Experience & Skills

- 8+ years of experience in Digital Manufacturing, Serialization, MES, Supply Chain Systems, or Track & Trace.
- Strong experience with pharmaceutical serialization and traceability.
- Experience managing enterprise applications in regulated/GxP environments.
- Strong understanding of L1–L5 serialization architecture and data flows.
- Hands-on experience with Antares platforms such as F2D2, Track4, Sentry, or equivalent serialization platforms.




- Knowledge of EMVS, DSCSA, and equivalent global serialization regulations.
- Experience with serial number management, aggregation, commissioning, decommissioning, shipment, and regulatory reporting.
- Understanding of integrations/data exchanges between serialization platforms, ERP, CMOs, logistics providers, affiliates, and health authorities.
- Familiarity with APIs, file-based exchanges, SaaS and hybrid application landscapes.
- Experience with Computerized System Validation (CSV), data integrity, audit trails, and compliance.
- Proven experience managing complex cross-functional initiatives and software vendors.

Leadership Competencies

- Strong ownership and accountability for business outcomes.
- Excellent stakeholder management and communication skills.
- Strong analytical and problem-solving abilities.
- Ability to influence across global and matrix organizations.
- Customer-focused and results-oriented mindset.
- Ability to balance strategic product ownership with operational execution.

Important: This is a strategic Product Owner / functional lifecycle ownership role. Enterprise architecture, technical standards, and integration architecture remain with the Enterprise Architect; the Product Owner provides business and functional direction.

About ConsultBae

ConsultBae is a recruitment and AI data services company offering talent acquisition, IT staffing, AI data services, and e-learning solutions. The company provides end-to-end recruitment and workforce solutions to organizations across India and global markets.

ConsultBae- https://consultbae.com/

📌 Product Owner – Serialization & Traceability (India)
🏢 Consultbae India
📍 India