Senior Quality Management Systems Specialist – Europe

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🔥 0 minutes ago

🌐 Spain, United Kingdom, +3 more countries – Remote

🇪🇸 Spain – Remote 🇬🇧 United Kingdom – Remote 🇧🇬 Bulgaria – Remote 🇵🇱 Poland – Remote 🇭🇷 Croatia – Remote

⏰ Full Time

🟠 Senior

✨ Quality Specialist

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Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.

📋 Description

• Manage planned and unplanned Quality Management Document deviations in accordance with Worldwide procedures • Receive departmental objectives and participate in determining unit goals and strategies • Support stakeholder training related to Quality Management System tools and procedures • Develop and deliver training content for Quality Management tools and procedures • Supervise maintenance of QMS trackers, tools, and electronic systems • Support external dissemination of Worldwide’s Quality Management records • Conduct quarterly trend analyses of planned and unplanned deviations • Report trends and KPIs related to QMD deviations to the appropriate Governance Committee

🎯 Requirements

• Bachelor’s degree or 4-year degree equivalent in a scientific discipline • Minimum of 3 years of experience working in clinical operations, monitoring, or equivalent • Experience supporting noncompliance, Quality Issues, and CAPAs within the last 2 years • Previous experience as an end user or equivalent in a QMS process • Awareness of domestic and international GxP regulatory requirements • Strong Microsoft Office skills, including Excel, Word, Outlook, PowerPoint, and SharePoint • Audit or inspection support experience preferred • Exceptional written and oral fluency in English • Professional, effective, clear, and consistent verbal and written communication • Collaborative, customer-focused approach • Critical thinking and ability to triage and escalate requests and concerns • Detail-oriented work style • Ability to manage workload priorities and communicate challenges and potential solutions to management • Experience with electronic Quality Management Systems is an asset

🏖️ Benefits

• Diverse and inclusive work environment • Supportive and cohesive teams • Accessible, hands-on leaders • Employee training and development opportunities • Equal employment opportunities • Exceptional employee experiences