Director of Quality Assurance

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
• Hands-on experience or exposure with:

• Quality Assurance
• Quality Management Systems (QMS)
• Quality Control Oversight

• 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

$160,000 - $180,000 annually (depending on experience and qualifications)

• 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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