Digital Quality Systems Specialist

Digital Quality System Specialist

Location: Ireland

Company: Pharmaceutical

Role Overview

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)

Desirable Experience

• 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
• Additional European language skills beneficial