Quality Analyst

📋 Description

• • As a Quality Analyst at Clario, you will play a vital role in ensuring the integrity of clinical studies and participant safety by supporting the Quality Management System (QMS) and partnering with Clinical Operations, Data Management, and Safety teams to manage Quality Events and CAPAs that impact study conduct and data quality.
• • Your day-to-day responsibilities will include generating quality metrics, implementing and maintaining QMS processes, managing CAPA responses for internal and external audits, developing and distributing KPIs, creating documentation for workflows and SOPs, assisting with updates to Standard Work Instructions, prioritizing QA tasks, and tracking deliverables while escalating issues when necessary.
• • You will join a mission-driven team at Clario, a company dedicated to transforming lives by unlocking better evidence, where your work directly contributes to bringing life-changing therapies to patients faster through rigorous quality assurance in clinical research.
• • In this role, you will develop expertise in FDA-regulated QMS, CAPA processes, and regulatory compliance (GDP, GCP, 21 CFR Part 11, ISO 9001/13485), strengthen your analytical and documentation skills, and grow your ability to drive continuous improvement in a global, collaborative environment.