Global Labeling Systems Lead

Position Summary

The Global Labeling Systems Lead is responsible for sustaining and advancing all global labeling systems
that support design and manufacturing. This role serves as a senior technical contributor and
system subject matter expert while providing day to day supervision for a small team (1–2 direct reports). The
position partners closely with Quality, Regulatory, IT, and Operations to ensure compliant, efficient, and scalable
labeling solutions across the product lifecycle. 

This position can be based at our Morrisville, NC, Maple Grove, MN, or Athlone, Ireland office

Principal Responsibilities

•    Sustain and enhance global labeling system software, hardware, and supporting processes. 
•    Develop and support future iterations of complete labeling system solutions, including software, equipment, and workflows. 
•    Serve as technical owner for labeling systems (e.g., Veraciti, printing, translation solutions), ensuring system performance, compliance, and reliability.
•    Lead system related validation activities (software and hardware), including documentation, testing, and execution. 
•    Serve as the primary point of contact for labeling business process ownership.
•    Deploy and administer labeling systems, including authored and approved Work Instructions (WIs) and Standard Operating Procedures (SOPs). 
•    Support deployment of labeling solutions to new manufacturing or distribution sites, including blueprinting, process design, implementation, and validation support. 
•    Provide functional leadership for 1–2 direct reports, including task prioritization, technical guidance, and job development. 
•    Serve as the primary point of contact for labeling system issues, troubleshooting, and resolution.
•    Identify and support continuous improvement opportunities related to labeling systems, processes, and compliance posture. 
•    Support departmental initiatives and other responsibilities assigned by management. 
•    Ensure compliance with company policies, procedures, and quality system requirements.

Education / Experience Requirements

•    Bachelor’s Degree required. 
•    5+ years of experience in system architecture, system design, or equivalent technical roles. 
•    Experience in software or process design and validation in a regulated environment is strongly preferred. 
•    Labeling experience in a regulated medical device/pharma industry. 
•    Prior people management or supervisory experience is a plus but not required.

Specialized Skills / Other Requirements

•    Working knowledge of validation principles, technical documentation, and regulated system environments. 
•    Strong technical aptitude in leading labeling software and system integrations. 
•    Excellent attention to detail with an understanding of the impact of labeling on patient safety and market access. 
•    Ability to work independently with minimal supervision while managing priorities and deadlines. 
•    Highly effective communicator capable of clearly conveying technical information to cross-functional partners and leadership. 
•    Demonstrated problem solving skills in complex or undefined situations. 
•    Proficiency with standard business tools (e.g., Microsoft Office). 

TRAVEL REQUIRED: 5-10 %

WORKING ENVIRONMENT:
☒ Office/Professional        ☐ Plant/Manufacturing    ☐ Remote/Field     ☐ Laboratory

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