Quality System Specialist

Role Overview

• Support the development and upkeep of Group QMS documentation (policies, processes, SOPs, templates).
• Contribute to process mapping, analysis, and redesign to drive efficiency and compliance.
• Ensure documentation aligns with applicable standards such as ISO 15189, ISO 9001, and GxP (where relevant).
• Assist markets in implementing Group QMS processes and reducing unnecessary variation.
• Support global adoption through training, communication, and ongoing follow-up.
• Provide day-to-day support to eQMS users, including troubleshooting, training, and user access management.
• Support configuration changes, module deployment, system upgrades, and validation activities.
• Identify and implement automation opportunities to enhance digital workflows.
• Collaborate with IT, vendors, and market teams to ensure stability and continuous improvement of the system.
• Create training materials, user guides, and learning content for QMS processes.
• Support and deliver training to teams across markets and act as a central point of contact.
• Develop, track, and analyze KPIs and quality performance metrics.
• Prepare reports and presentations that highlight trends and improvement needs for management.

Requirements

• Bachelor’s or Master’s degree (or equivalent).
• 5–7 years of experience in Quality within the life sciences industry.
• Experience working with global or multisite Quality Management Systems.
• Strong project management capability and high attention to detail.
• Experience providing training and user support for QMS tools.
• Strong analytical and problem-solving skills.
• Ability to collaborate effectively across teams, countries, and functions.
• Knowledge of ISO 9001, ISO 15189, or ISO 13485.
• Expertise in process mapping and quality processes.
• Proficiency in MS Office; experience with QMS systems and Power BI is an advantage.
• Rigorous, organized, autonomous, with excellent communication skills.
• Fluent English (written and spoken).