🚀 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.
🔬 What You'll Do:- 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.
✅ What We're Looking For:
🎓 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🧫 Hands-on experience or exposure with:
- Quality Assurance
- Clinical Research
- Good Clinical Practice (GCP)
- FDA Regulations
- ICH Guidelines
- CAPA Management
- Internal Audits
- External Audits
- Regulatory Inspections
- Quality Management Systems (QMS)
- eQMS
- Vendor Audits
- Clinical Trial Compliance
- 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💰 Compensation Range $160,000 - $180,000 annually (depending on experience and qualifications)
Comprehensive Benefits📍 Please Note✅ On-site in Miami, FL✈️ Travel may be required to support QA initiatives, internal audits, regulatory inspections, and other ERG sites🇺🇸 Applicants must be authorized to work in the U.S.If this sounds like you—or someone in your network—I’d love to connect!#Quality
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Trials #Quality
Management #Compliance #Auditing #Life
Sciences #Pharmaceuticals #Clinical
Operations #Hiring #MiamiFL
