Application Manager, Global Labelling Systems

About the role

Travel required: up to 10%.

Position Summary: The Global Labeling Systems Application Manager (Kallik/Veraciti Platform) supports the day‑to‑day operation, continuous improvement, and user enablement of the company’s global labeling solution built on the Kallik platform. This role ensures the labeling system is stable, compliant, and scalable across regions, and that labeling workflows and integrations enable timely, accurate, and traceable label content changes. The role operates within a GxP-regulated medical device manufacturing environment subject to EU MDR/IVDR, ISO 13485, and 21 CFR Part 11, spanning multiple manufacturing sites. The incumbent will be expected to maintain validated state through periods of system and infrastructure change. Working closely with Regulatory Affairs, Quality, Supply Chain, Manufacturing, Packaging Engineering, and IT, the application manager partners to resolve incidents, implement enhancements, maintain validated state documentation, and drive consistent global adoption.

Responsibilities

• Provide Tier 2 / Tier 3 functional support for the Kallik labeling platform, including incident triage, root cause analysis, and resolution coordination.
• Own and maintain support procedures including troubleshooting guides, and known error libraries.
• Coordinate issue escalation with vendors and internal technical teams, ensuring timely resolution aligned to SLAs.
• Manage the ongoing vendor relationship with Kallik/Veraciti including licence tracking, platform roadmap engagement, upgrade planning, and escalation governance.
• Evaluate new platform capabilities against business requirements and regulatory constraints before adoption.
• Support global business processes for labeling including label creation, updates, approvals, versioning, and release.
• Configure and maintain system objects as applicable (e.g. label definitions, data mappings, user roles, routing/approval logic), following change control.
• Partner with Regulatory/Quality to ensure workflows and system