Director - Quality Assurance & Automation (REMOTE

Quality Assurance (QA) Director Miami, FL | On-site Full-Time Help Advance Life-Saving Clinical Research Are you passionate about Quality Assurance , clinical trial compliance, GCP regulations, and leadership? We’re looking for a Quality Assurance (QA) Director to join a growing clinical research organization supporting Phase I-IV clinical trials across multiple therapeutic areas. If you thrive in a fast-paced clinical research environment and enjoy working with audits, CAPAs, regulatory inspections, quality systems, and cross-functional leadership teams , this could be your next opportunity. Lead and conduct internal audits to ensure compliance with study protocols and regulatory requirements ✔ Support Quality events, CAPA programs, audit readiness, and quality investigations ✔ Oversee internal and external audits , sponsor visits, and regulatory inspection activities ✔ Manage and supervise Quality Control plans and QA/QC personnel ✔ Review study documentation, Case Report Forms, Clinical Study Reports, and quality records ✔ Support and maintain the Quality Management System (QMS/eQMS) across clinical operations ✔ Collaborate with Site Leadership, Principal Investigators, Sponsors, CROs, and Operational Teams ✔ Serve as a Subject Matter Expert supporting Quality Assurance and Compliance activities ✔ Lead training oversight, quality metrics reporting, and continuous improvement initiatives ✔ Support FDA inspections, GCP compliance, vendor audits, and client engagement activities. ✅ Bachelor’s degree or higher in Life Sciences, Medicine, or a related field (or equivalent experience) Minimum 10 years in the pharmaceutical, clinical research, or medical device industry, including conducting internal and external audits Quality Assurance • CAPA Management • Regulatory Inspections • Quality Management Systems (QMS) • Site Leadership • Quality Control Oversight • Clinical Operations Bonus • Bilingual Spanish preferred • 5+ years participating in FDA or regulatory agency inspections preferred • Experience with 21 CFR Part 11 and Computer System Validation preferred • Experience in project management or leadership of high-volume clinical trials strongly desired On-site in Miami, FL ✈️ Travel may be required to support QA initiatives, internal audits, regulatory inspections, and other ERG sites If this sounds like you—or someone in your network—I’d love to connect! #QualityAssurance #QADirector #ClinicalResearch #GCP #FDA #ICH #CAPA #ClinicalTrials #QualityManagement #Compliance #Auditing #LifeSciences #Pharmaceuticals #ClinicalOperations #Hiring #MiamiFL