Digital Quality Systems Specialist

ARTO; Leinster; On-site; EUR 50,000 - 70,000; Full time

Job summary

ARTO is seeking an experienced Quality Systems professional in Leinster to manage global electronic Quality Management Systems (eQMS) in a regulated environment. This role involves system administration, configuration, and compliance assurance, collaborating with cross-functional teams for operational efficiency.

The ideal candidate has a relevant degree, 4+ years in regulated industries, and expertise in eQMS. Responsibilities include user access management, system performance monitoring, and continuous improvement initiatives.

Qualifications

• 4+ years’ experience in pharmaceutical, life sciences, or regulated industries.
• 3+ years hands-on experience with Quality Management Systems.

Responsibilities

• Administer and support global eQMS platforms.
• Manage user access and system permissions.
• Coordinate with local administrators for alignment.
• Monitor system performance and resolve technical issues.
• Assist with system configuration and enhancements.
• Support validation activities and maintain documentation.
• Ensure compliance with GxP and quality processes.
• Contribute to digital quality initiatives.

Skills

eQMS administration

GxP environments

system configuration

troubleshooting

end-user support

analytical skills

communication skills

cross-functional collaboration

fluent English

Education

Degree in scientific, IT, engineering, or related discipline

Job description

We are seeking an experienced Quality Systems professional to support the management and continuous improvement of global electronic Quality Management Systems (eQMS) within a regulated environment. This role focuses on system administration, configuration, validation support, troubleshooting, and driving process improvements while collaborating with international cross‑functional teams to ensure compliance and operational efficiency.

Key Responsibilities

• Administer and support global eQMS platforms, ensuring compliance and system effectiveness
• Manage user access, licences, and system permissions across multiple sites
• Coordinate with local administrators to maintain alignment between global and site‑level processes
• Monitor system performance, resolve technical issues, and manage support requests efficiently
• Assist with system configuration, upgrades, enhancements, and implementation activities
• Support validation activities, including documentation review and protocol execution
• Maintain training materials, SOPs, and system‑related documentation
• Ensure compliance with GxP requirements, data integrity standards, and quality processes
• Contribute to digital quality initiatives aimed at improving workflows and operational efficiency
• Identify system improvement opportunities and support continuous improvement activities
• Collaborate with Quality, IT, and cross‑functional teams to ensure process consistency
• Assist with internal and external audits, inspections, and compliance activities

Candidate Profile

• Degree in a scientific, IT, engineering, or related discipline
• 4+ years’ experience in pharmaceutical, life sciences, or other regulated industries
• 3+ years hands‑on experience with Quality Management Systems or regulated digital platforms

Required Skills & Experience

• Strong knowledge of eQMS administration and support
• Experience working in GxP environments with understanding of EU, FDA, and ICH requirements
• Skills in system configuration, troubleshooting, and end‑user support
• Knowledge of Computer System Validation (CSV) and validation lifecycle activities
• Ability to work across global and local teams in a multi‑site environment
• Strong analytical, organisational, and problem‑solving abilities with high attention to detail
• Strong communication skills with experience delivering training and user support
• Effective cross‑functional collaborator in multinational environments
• Fluent English (written and spoken)
• Familiarity with GAMP guidelines and digital transformation initiatives
• Experience with system implementations, upgrades, or optimisation projects
• Exposure to ISO standards and regulated documentation frameworks
• Experience in global or multi‑site organisations