Global Quality Coordinator
About The Position
Premier Research is seeking a Global Quality Coordinator to join their Functional Services Provider (FSP) team. This role supports biotech, medtech, and specialty pharma companies in transforming life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. Premier Research values its team members as the most valuable asset, offering opportunities for growth, skill development, and work-life balance. The coordinator will be an essential part of the team, contributing to the delivery of medical innovation and ensuring the effectiveness of the Global Quality Management System and the quality of deliverables.
Requirements
- Bachelor’s degree, or international equivalent from an accredited institution, in Health or Life Sciences, or equivalent experience
- At least 5 years specialized GCP and ISO experience in auditing clinical trials including auditing internal processes and performing vendor audits
- Ability to interpret research protocols and audit medical records
- Experience with paper-based data management systems; experience with RDC/EDC data
Nice To Haves
- Experience in hosting and responding to regulatory inspections preferred
Responsibilities
- Assists and participates in contracted audits (investigator sites, trial master files, databased, study reports etc.) and internal audits (systems, processes, vendors, computer system validation etc.) across global operations, (including preparation of audit plans, audit checklists, audit reports and certificates
- Helps project manage compliance issues, running investigations with operational teams
- Assists the maintenance of the Global Quality Management System
- Supports Premier Research in ensuring the effectiveness of the Quality Management System and the quality of the deliverables
- Assist in the conduct detailed QA review of SOPs prior to approval
- Drives input into process improvement initiatives across the company
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What This Job Offers
Career Level
Senior
