Director of Quality Assurance

🚀 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!

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