Job Description
🚀 Quality Assurance (QA) Director
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📍 Miami, FL | On-site
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🗓 Full-Time
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🌱 Help Advance Life-Saving Clinical Research
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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.
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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.
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🔬 What You'll Do
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✔ Lead and conduct internal audits to ensure compliance with study protocols and regulatory requirements
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✔ Support Quality events, CAPA programs, audit readiness, and quality investigations
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✔ Oversee internal and external audits, sponsor visits, and regulatory inspection activities
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✔ Manage and supervise Quality Control plans and QA/QC personnel
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✔ Review study documentation, Case Report Forms, Clinical Study Reports, and quality records
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✔ Support and maintain the Quality Management System (QMS/eQMS) across clinical operations
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✔ Collaborate with Site Leadership, Principal Investigators, Sponsors, CROs, and Operational Teams
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✔ Serve as a Subject Matter Expert supporting Quality Assurance and Compliance activities
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✔ Lead training oversight, quality metrics reporting, and continuous improvement initiatives
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✔ Support FDA inspections, GCP compliance, vendor audits, and client engagement activities.
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✅ What We're Looking For
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🎓 Bachelor’s degree or higher in Life Sciences, Medicine, or a related field (or equivalent experience)
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🧪 Minimum 10 years in the pharmaceutical, clinical research, or medical device industry, including conducting internal and external audits
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🧫 Hands-on experience or exposure with:
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• Quality Assurance
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• Clinical Research
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• Good Clinical Practice (GCP)
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• FDA Regulations
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• ICH Guidelines
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• CAPA Management
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• Internal Audits
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• External Audits
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• Regulatory Inspections
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• Quality Management Systems (QMS)
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• eQMS
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• Vendor Audits
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• Clinical Trial Compliance
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• Site Leadership
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• Quality Control Oversight
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• Clinical Operations
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Bonus
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• Bilingual Spanish preferred
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• 5+ years participating in FDA or regulatory agency inspections preferred
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• Experience with 21 CFR Part 11 and Computer System Validation preferred
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• Experience in project management or leadership of high-volume clinical trials strongly desired
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💰 Compensation Range
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$160,000 - $180,000 annually (depending on experience and qualifications)
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Comprehensive Benefits
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📍 Please Note
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✅ On-site in Miami, FL
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✈️ Travel may be required to support QA initiatives, internal audits, regulatory inspections, and other ERG sites
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🇺🇸 Applicants must be authorized to work in the U.S.
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If this sounds like you—or someone in your network—I’d love to connect!
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