Director of Quality Assurance

🔬 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 Assurance #QADirector #Clinical Research #GCP #FDA #ICH #CAPA #Clinical Trials #Quality Management #Compliance #Auditing #Life Sciences #Pharmaceuticals #Clinical Operations #Hiring #MiamiFL