Quality Analyst

Quality Analyst

Clario

Budapest or Remote, Hungary

Our Quality Analyst (f/m/x) in full time (40h/week) plays a vital role in ensuring the integrity of our clinical studies and the safety of our participants. Working at the heart of our Quality Management System (QMS), this role partners closely with Clinical Operations, Data Management, and Safety teams to manage Quality Events and CAPAs that impact study conduct, data quality, and participant health. If you're passionate about quality and continuous improvement, we invite you to join us in transforming lives through better evidence. Manage Quality Events and CAPAs to address impacts to study conduct, data quality, and participant health and safety issues.

What You’ll Be Doing

• Generate quality metrics and support process improvement initiatives within the Quality Unit;
• Implement and maintain Quality Management Systems (QMS);
• Manage CAPA responses for internal/vendor audits and external audit observations; ensure timely follow-up;
• Develop and distribute KPIs and other key quality metrics;
• Create documentation for new workflows, procedures, training, and support materials;
• Assist with updates to Standard Work Instructions and SOPs;
• Prioritize multiple QA tasks to align with corporate quality objectives;
• Track deliverables and escalate issues when necessary.

What We Look For

• Bachelor’s degree in a scientific or technical field;
• 2–5 years of experience in a Quality Assurance role within an FDA-regulated environment;
• Knowledge of GDP, GCP, and regulatory frameworks (21 CFR Part 11, 21 CFR 820.20, ISO 9001/13485);
• Experience with QMS and CAPA processes;
• Proficiency in Excel;
• Exceptional English written and verbal communication;
• Strong attention to detail and organizational skills;
• Ability to work independently and collaboratively;
• Skilled in editing, proofreading, and clear documentation.