Application Manager, Global Labelling Systems

Teleflex•Durham, NC

3d•Remote

About The Position

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.

Requirements

Bachelor’s degree in information systems, Engineering, Life Sciences, Supply Chain, or related field (or equivalent experience).
5+ years of experience supporting enterprise applications in regulated environments (medical devices, pharma, diagnostics, or similar), including direct experience with labeling or artwork management systems.
Hands-on experience supporting labeling systems, regulated document platforms, PLM, or comparable workflow tools.
Strong understanding of labeling lifecycle concepts: controlled content, versioning, approvals, and traceability.
Experience working with cross-functional stakeholders and managing issues through resolution in a global environment.
Proficiency with incident/change management practices (e.g., ITIL concepts), including documentation and audit-ready evidence.
Working knowledge of EU MDR/IVDR labeling requirements including UDI, language/country requirements, and label variant management across markets.
Experience with GxP-compliant SDLC including CSV, change impact assessment, and validation documentation (IQ/OQ/PQ or equivalent).
Professional proficiency in English required

Nice To Haves

German language skills advantageous for European manufacturing site engagement.
Experience with Kallik/Veraciti platform implementations or operations (template management, label rules, workflow configuration).
Working knowledge of SAP integration touchpoints (IDocs/interfaces, master data dependencies, SAP DMS linkages).
Working knowledge of enterprise PLM integrations, supporting alignment of interfaces, master data, and lifecycle states across connected systems.
Familiarity with CSV/Excel-based mapping, basic SQL queries, and log analysis for troubleshooting.
Experience supporting validated systems (e.g., GxP), including SDLC documentation, UAT, and release governance.
Exposure to electronic signatures, audit trails, and compliance frameworks (e.g., ISO 13485, 21 CFR Part 11 concepts).
Experience supporting multi-language label content, translation management workflows, and country-specific label variant control.
Exposure to print-and-apply or shop-floor label execution integration (e.g., NiceLabel, Loftware, or Bartender) and the boundary between content management and execution systems.

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 controls support compliant approvals, audit trails, and traceability.
Configure and maintain approval workflow routing logic, electronic signature controls, and audit trail mechanisms within Kallik/Veraciti, ensuring compliance with 21 CFR Part 11 and applicable regulatory requirements.
Support labeling system activities in regulated environments (e.g., medical devices, pharma), including: Maintaining validated state artifacts (e.g., requirements, test scripts, traceability matrices, release notes).
Supporting change impact assessments, validation testing, and controlled deployment documentation.
Participate in internal/external audits and inspections, providing evidence for system controls, access management, and electronic approvals where applicable.
Ensure system access and roles are maintained under least privilege and consistent global standards.
Gather and translate business needs into user stories/requirements for system enhancements and integrations.
Support backlog grooming, prioritization discussions, and release planning in partnership with system owner/product owner.
Execute or coordinate UAT activities: test planning, test execution, defect tracking, and signoff coordination.
Analyze recurring issues and process bottlenecks; recommend improvements to increase labeling cycle time, right-first-time quality, and user experience.
Support and troubleshoot integrations between Kallik and enterprise platforms such as: ERP (e.g., SAP ECC/S/4HANA), Document management repositories (e.g., SAP DMS/ECM), PLM or regulatory content sources (as applicable), Shop-floor label execution systems (e.g., NiceLabel/Loftware), define and maintain the operational boundary between Kallik content management and print execution, ensuring end-to-end label traceability from artwork approval through to print.
Partner with Master Data teams to resolve data quality issues that impact label output (e.g., UoM, identifiers, country/market attributes, translations).
Communicate release updates, known issues, planned downtime, and best practices to global user communities.