Quality Assurance Coordinator

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Clario

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1973

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 Private Equity Round on 2019-10

Healthcare • Consulting • Logistics

Clario is a company specializing in accelerating clinical trials from initiation to implementation through advanced technologies and services. Since 2018, Clario has revolutionized endpoint analyses in clinical trials by integrating over 30 artificial intelligence-enabled solutions across more than 600 active trials, enhancing data quality and patient privacy while expediting data collection processes. Clario provides a comprehensive clinical trial management platform, offering solutions such as eCOA, cardiac safety, medical imaging, precision motion, and respiratory services in various therapeutic areas including oncology, cardiology, and neurology. Known for its global reach, Clario supports clinical trials in over 100 countries with a strong focus on decentralized and hybrid trial models. The company's commitment to patient safety and innovation is reflected in their over 26,000 trials and involvement in numerous new drug approvals.

📋 Description

• Coordinate and support pre-audit, audit, inspection, and post-inspection activities under Quality Assurance and Regulatory Compliance leadership • Schedule audits and inspections and manage logistics, timelines, and stakeholder communications • Organize required documentation, supporting evidence, and subject matter expert schedules • Collaborate with management and cross-functional teams to ensure audit and inspection readiness • Review documentation for completeness and identify gaps, risks, or missing information • Assist with obtaining, tracking, and organizing responses to audit findings and inspection observations • Maintain audit and inspection archives and accurately store documentation in designated repositories • Coordinate project documents, schedules, data requests, and stakeholder activities for quality and regulatory compliance • Support audit and inspection libraries and quality systems documentation • Assist with special projects, process improvement initiatives, and other quality-related activities • Support global audit and inspection activities across multiple time zones • Contribute to quality, compliance, continuous improvement, and operational excellence

🎯 Requirements

• Associate’s degree, Bachelor’s degree, or equivalent combination of education, certifications, and relevant experience • 1–3 years of experience in a GxP-regulated environment or other highly regulated industry • Willingness to work in the US time zone, 5pm to 2am • Experience coordinating complex schedules, meetings, documentation, or project-related activities • Exposure to audits, regulatory inspections, quality systems, or compliance programs preferred • Working knowledge of ICH GCP, 21 CFR Part 11, 21 CFR 820, ISO 9001, ISO 13485, ISO 27001, or related frameworks preferred • Proficiency with Microsoft Office applications, including Outlook, Word, Excel, PowerPoint, and Microsoft Teams • Strong organizational and project coordination skills • Excellent written and verbal communication skills in English • Strong analytical skills, attention to detail, and commitment to documentation accuracy • Experience with Quality Management Systems such as TrackWise or Veeva is an added advantage • Ability to work independently while collaborating effectively with global teams and stakeholders • Flexibility to periodically work non-standard hours for global audits, inspections, and compliance activities • Ability to perform successfully in deadline-driven environments while maintaining professionalism and quality

🏖️ Benefits

• Competitive pay and incentives • Provident fund and medical insurance • Engaging employee programs and local events • Modern office spaces and remote work flexibility • Opportunities for professional development and growth within a global organization