The eQMS System Administrator is responsible for the configuration, validation, and ongoing administration of the electronic Quality Management System (eQMS). This role serves as the technical and process owner for quality system workflows, ensuring they are compliant, validated, user‑friendly, and aligned with regulatory requirements and business needs.
The eQMS System Administrator partners closely with Quality, Regulatory, IT, and cross‑functional stakeholders to develop and maintain workflows for Complaints, CAPA, Change Control, Training, Document Control, Audits, Supplier Quality, Controlled Substances, and Risk Management. This role also owns quality system reporting, KPIs, and dashboards to support Management Review and continuous improvement initiatives.
Key Responsibilities
eQMS Administration & Governance
Serve as the eQMS System Administrator and Business Process Owner for quality system workflows.
Configure, maintain, and optimize eQMS modules, workflows, forms, user roles, and permissions.
Ensure system configuration aligns with approved SOPs, regulatory expectations, and data integrity principles.
Act as primary liaison between Quality and IT for eQMS-related issues, enhancements, and upgrades.
Support system access management, periodic access reviews, and audit readiness activities.
Workflow Development & Validation
Develop, configure, and maintain validated eQMS workflows, including: Complaints, CAPA, Change Control, Training, Document Control, Audits, Supplier Quality, Controlled Substances, Risk Management
Author and execute system validation documentation (e.g., URS, FRS, IQ/OQ/PQ, validation summaries).
Assess impact of system changes and support change control activities related to the eQMS.
Ensure workflows support traceability, escalation, approvals, and regulatory reporting requirements.
Reporting, Metrics & Dashboards
Design, develop, and maintain QMS reports, KPIs, and dashboards to support:
Track and trend quality system metrics (e.g., CAPA aging, complaint trends, training compliance, audit findings).
Analyze data to identify systemic issues and continuous improvement opportunities.
Present quality system performance data to Quality leadership and cross‑functional stakeholders.
SME Support General Quality Systems SME Support
Provide general quality systems SME support (e.g. Document Control, CAPA, Supplier Quality, Validation, Change Control, etc.).
Ensure procedures and document workflows comply with document control SOPs and regulatory expectations.
Support QMS training programs, including role-based training assignments and effectiveness tracking.
Provide end-user support and troubleshooting related to eQMS workflows and reporting.
Audit & Compliance Support
Support internal, customer, and regulatory audits by providing eQMS records, reports, and system evidence.
Ensure eQMS configuration supports compliance with applicable regulations and standards (e.g., FDA, ISO).
Participate in inspection readiness activities related to electronic records and data integrity.
Support continuous improvement of quality system processes and system usability.
Additional Responsibilities
The above statements describe the general nature and level of work being performed. Additional responsibilities may be assigned as required.
Experience Required
Minimum 4–6 years of experience in Quality Systems, Quality Assurance, or regulated systems administration.
Hands-on experience administering and validating an eQMS in a regulated industry (medical device, pharmaceutical, or combination products).
Experience developing workflows and reporting for multiple quality system processes.
Education
Bachelor’s degree in science, engineering, information systems, or a related field.
Specialized Knowledge/Skills
Strong understanding of regulated quality systems and electronic records requirements.
Working knowledge of FDA regulations (e.g., 21 CFR 210, 211, 820, 803, 806, Part 11) and ISO standards (e.g., ISO 13485, ISO 14971).
Experience with system validation and change control.
Strong analytical, reporting, and data visualization skills.
Excellent written and verbal communication skills.
High attention to detail with strong organizational and planning skills.
Ability to work cross‑functionally and manage multiple priorities.
PC/Equipment
Work Environment/Physical Demands
General office or remote work environment.
Availability to support audits and system activities during U.S. business hours.
Limited travel may be required.
