GCP Director of Quality Assurance and Compliance
Evolution Research Group
full-time
Posted on:
Location Type: Office
Location: Miami • Florida • United States
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Job Level
Tech Stack
About the role
- ensuring that day-to-day clinical trial operations at the CPMI site are conducted in compliance with study protocols, FDA regulations, and ICH/GCP guidelines.
- provides oversight and reporting to Operational Leadership to maintain the integrity and quality of all site activities.
- Conducting internal audits
- Monitoring training completion and associated metrics
- Providing support and consultation for Quality events and CAPAs
- Overseeing and assisting with internal and external audits
- Managing and supervising Quality Control plans and QC staff
- Maintaining all Quality-related activities within the clinic
- supporting the overall Quality Management System for these sites to ensure quality assurance, quality control, compliance, and auditing activities related to study conduct.
Requirements
- Thorough understanding of Good Clinical Practices (GCP), Code of Federal Regulations (CFR), and HIPAA as they apply to clinical research.
- Bachelor’s degree or higher in life sciences, medicine, or a related field (or equivalent experience).
- Bilingual Spanish highly preferred
- Minimum of 10 years in the pharmaceutical, clinical, or medical device industry, including conducting internal and external audits.
- At least 5 years of experience participating in FDA or other regulatory agency inspections (preferred).
- Extensive experience managing CAPA programs with a focus on GCP compliance, ensuring timely completion and deliverables.
- Background in project management, site leadership, or oversight of high-volume clinical trials strongly desired.
- Experience with 21 CFR Part 11 and aspects of Computer System Validation (preferred but not required).
Benefits
- competitive benefits include medical and dental coverage
- a matching 401(k)
- paid time off to recharge
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Good Clinical Practices (GCP)Code of Federal Regulations (CFR)HIPAAQuality Control (QC)Corrective and Preventive Actions (CAPA)Clinical trial operationsInternal auditsExternal auditsComputer System ValidationProject management
Soft Skills
OversightConsultationSupervisionCommunicationLeadership