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 mapping, gap analysis, data integrity assurance Spreadsheet Validation Risk-based planning, testing (IQ/OQ/PQ), detailed documentation, change control around computer systems for quality, manufacturing, and device function to ensure they're safe, reliable, and compliant Procedural documentation development pertinent to Computer System Validation Extensive experience in medical device IT, Quality Systems, or Digital Health Deep understanding of medical device regulations (e.

g., ISO 13485, ISO 14971, EU

MDR 2017/745, MDSAP

) Proficiency with relevant software, data management, cybersecurity, and digital platforms Competencies Be Agile

• Innovates and adapts quickly, approaching change with curiosity while persisting through obstacles. Be Customer Centric
• Considers the needs, experiences and feedback of customers in all we do. Be People-Focused
• Builds trust and collaborates with an inclusive and empathetic approach. Be Performance Driven
• Operates with an ownership mindset, driving meaningful outcomes. Live The Schneiders' Legacy, Our Noble Purpose
• Passionately serves Our Mission and Vision, while demonstrating the Immutable Principles. Our Total Rewards package in aggregate is above market and includes competitive pay, paid time off programs, peer-to-peer recognition, health and life insurance, wellness programs and incentives, and generous retirement savings. The anticipated base pay range for this position is $108,000
• $155,000 yearly.

The actual salary varies based on applicant's location, education, experience, skills, abilities, and other legitimate business factors. This position is also eligible to participate in the Hollister Corporate Bonus Plan. The Company's health and welfare benefits include medical, prescription, dental, vision, spending/savings accounts, disability, company paid (parental and caregiver) leaves, statutory leaves/disability programs, accident, life, wellbeing, education assistance, adoption assistance, and voluntary benefit programs. The Company's 401(k) Retirement Savings Plan includes: auto-enrollment, ROTH, vesting and eligible participants "safe harbor" matching contributions. The Company's paid time off benefits include: 11 paid holidays, paid vacation based on length of service and exempt/non-exempt status, and sick days based on statutory requirements and/or exempt/non-exempt status. The Company's additional benefits include: education assistance and adoption assistance benefit programs. About Hollister Incorporated Hollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide. The company spearheads the advancement of innovative products for ostomy care, continence care and critical care, and also creates educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services, as well as its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings. EOE Statement All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Job Req ID:

35988