Job Title: QA Supervisor

Work Location: Miami-Dade County, Florida

Summary:

The QA Supervisor oversees clinical research operations by inspecting and evaluating processes, ensuring adherence to regulations and guidelines, and supporting quality control and assurance activities. This role involves data review, risk management, audit support, and training to foster a culture of quality within clinical research studies.

Responsibilities:

• Oversee and evaluate clinical research processes to ensure compliance with FDA regulations, ICH GCP guidelines, and site SOPs.
• Conduct quality control reviews of study documents, logs, and master files to ensure accuracy, completeness, and audit readiness.
• Identify, document, and communicate inconsistencies or areas needing clarification to site leadership and quality teams.
• Support audit preparation, facilitation, and closure, including tracking CAPA activities and maintaining quality management system metrics.
• Serve as a subject matter expert for electronic quality management systems and provide back-end support for regulatory inspections.
• Train, mentor, and support operational team members on quality assurance and control practices and regulatory requirements.
• Communicate professionally with internal teams, sponsors, monitors, and auditors, ensuring timely and accurate correspondence.
• Stay current with new FDA, GCP, and ICH regulations and guidelines, and assist in developing and updating work practices as needed.

Qualifications:

• 2-year degree in a related field required.
• Minimum of 5 years of experience conducting or managing clinical pharmaceutical/device research studies or equivalent experience in the clinical research industry.
• Thorough knowledge of clinical research concepts, practices, FDA regulations, and ICH guidelines regarding drug development phases and data management methods.
• Ability to train staff on regulatory requirements, Good Clinical Practices (GCP), and International Conference of Harmonization (ICH) guidelines.
• Proficiency in medical terminology.
• Excellent interpersonal, written, and verbal communication skills.
• Basic computer skills, including proficiency with Word, Excel, and clinical research industry applications.
• Demonstrated leadership and team-building abilities.

Published Category: Quality & Validation