Senior QA Director — Clinical Trials & Regulatory Compliance

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

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,