Director of Quality Assurance

BioTalent; Miami (FL); On-site; USD 160,000 - 180,000; Full time

Job summary

BioTalent is seeking a Quality Assurance Director to lead QA for a growing clinical research organization conducting Phase I–IV trials across multiple therapeutic areas. You will drive internal audits, CAPA programs, and regulatory inspections, ensuring GCP compliance and a robust QMS across study operations.

Based in Miami, on-site with travel to support QA initiatives, you will mentor teams, report quality metrics, and partner with investigators, sponsors, CROs, and operations to advance safe,

Qualifications

• Bachelor’s degree or higher in Life Sciences, Medicine, or related field (or equivalent)
• Minimum 10 years in pharma/clinical research/medical device with internal and external audits
• Hands-on experience with QA, QMS, and Quality Control Oversight

Responsibilities

• Lead and conduct internal audits to ensure regulatory and protocol compliance
• 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 across clinical operations
• Collaborate with Site Leadership, Principal Investigators, Sponsors, CROs, and Operational Teams
• Serve as a Subject Matter Expert supporting QA and Compliance activities
• Lead training oversight, quality metrics reporting, and continuous improvement initiatives
• Support FDA inspections, GCP compliance, vendor audits, and client engagement activities

Skills

Quality Assurance

Audits

CAPA

GCP compliance

Regulatory inspections

Quality metrics

Leadership

Education

Bachelor’s degree or higher

Tools

QMS/eQMS

21 CFR Part 11

Computer System Validation

Job description

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
• Quality Management Systems (QMS)
• Quality Control Oversight

Bonus

• 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)

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!

#QualityAssurance #QADirector #ClinicalResearch #GCP #FDA #ICH #CAPA #ClinicalTrials #QualityManagement #Compliance #Auditing #LifeSciences #Pharmaceuticals #ClinicalOperations #Hiring #MiamiFL