Global QMS Information Systems Lead

We Make Life More Rewarding and Dignified 

Location: ​Libertyville​
Department: ​Quality 

 

Summary

The Global QMS Information Systems Lead is responsible for leading the global strategy, implementation, and continuous improvement of the electronic Quality Management System (eQMS) and related digital systems. This involves ensuring these systems are properly designed, installed, and maintained to meet established user needs, functional specifications, and all applicable regulatory requirements (e.g., ISO 13485, GAMP 5, IEC 62304, FDA QSR, 21 CFR Part 11), minimizing risks to data integrity, product safety and efficacy, enabling data integrity, process efficiency, traceability, and global collaboration.

 

This role has direct involvement with the introduction and maintenance of global software systems utilized to support the global QMS. Additionally, as a Quality Assurance representative, this position will support delivery of quality system software application validations (inclusive of developing and executing validation plans, protocols and testing documentation) in collaboration with IT and system owner cross functional teams to ensure effective and compliant computerized systems. This role will also support the ongoing maintenance of computerized systems at Hollister Incorporated and will support investigations, resolve potential data integrity issues, and implement process improvements to mitigate any risks to the validated state.

 

Responsibilities

 

• Develop and manage the global eQMS roadmap, including system enhancements, integrations, and harmonization across regions
• Ensure alignment with regulatory frameworks (e.g., ISO 13485, FDA QSR, EU MDR)
• Implement, configure, and maintain modules (e.g., Document Control, CAPA, Change Control, training, complaint handling, supplier quality)
• Collaborate with IT to validate critical computerized systems per applicable regulatory documentation/control requirements
• Map and optimize QMS workflows to streamline global processes and eliminate redundancy
• Support digital traceability and integration of eQMS with ERP, PLM, MES systems
• Maintain regulatory compliance through system readiness and audit support, ensuring regulatory preparedness with system validation documentation, audit trails, etc.
• Manage large-scale projects, system implementations, and third-party vendor relationships
• Deliver global training for users and administrators on eQMS functionality and compliance
• Evaluate and implement new digital solutions (e.g., AI, cloud) to enhance efficiency and data utilization
• Provide guidance and actively participate as a project team member for software validation projects
• Generation/maintenance of software validation plans, protocols and reports to applicable standards and industry best practices
• Review / approval of software validation plans, requirements, protocols/ test scripts and final reports.

 

Essential Functions of the Role

• Communicate effectively via email, phone, and virtual platforms.
• Collaborate across departments to support organizational goals.
• Participate in cross-functional meetings and initiatives.
• Maintain and analyze data using tools like Excel, SAP, or HRIS systems.
• Prepare reports and dashboards for internal stakeholders.
• Ensure data accuracy and confidentiality in compliance with company and legal standards.
• Manage multiple priorities and deadlines in a fast-paced environment.
• Lead or support special projects aligned with departmental objectives.
• Demonstrate initiative in identifying process improvements or automation opportunities.
• Serve as a point of contact for internal and external stakeholders.
• Resolve inquiries and issues with professionalism and discretion.
• Maintain secure handling of sensitive information.
• Support audits and regulatory reporting as needed.

Education & Work Requirements

• Bachelor’s Degree with 8-12 years of related experience

Education & Work Preferences

• Experience in deploying and managing eQMS platforms (e.g., TrackWise, MasterControl, Veeva) and their integration with enterprise systems
• Experience in deploying and managing eQMS platforms (e.g., TrackWise, MasterControl, Veeva) and their integration with enterprise systems
  • Understanding of 21 CFR 11 validation, Computer System Validation (CSV), and software regulatory requirements
  • Proficient in system administration and design thinking - process