Job Title: GCP Director of Quality Assurance and Compliance Work Location: Miami-Dade County, Florida

Summary:

The GCP Director of Quality Assurance and Compliance is responsible for overseeing daily clinical trial operations to ensure compliance with study protocols, FDA regulations, and ICH/GCP guidelines. This leadership role involves mentoring staff, managing quality assurance initiatives, conducting audits, and supporting regulatory inspections. The position also plays a key part in maintaining and enhancing the Quality Management System across multiple clinical research sites.

Responsibilities:

• Lead and conduct audits of study documents and clinical reports to ensure regulatory and protocol compliance.
• Collaborate with site leadership and principal investigators to resolve and document quality issues efficiently.
• Oversee implementation of corrective and preventive actions, ensuring timely and accurate reporting to stakeholders.
• Facilitate sponsor audits, regulatory inspections, and assist with preparation activities as needed.
• Supervise and mentor quality assurance and quality control staff, fostering a culture of compliance and continuous improvement.
• Manage all aspects of the electronic Quality Management System and document control activities for the site and other locations as assigned.
• Participate in the oversight and execution of internal and external audits, including vendor and agency inspections.
• Support the maintenance and alignment of the Quality Management System with internal policies, SOPs, and regulatory requirements.

Qualifications:

• Bachelor’s degree or higher in life sciences, medicine, or a related field, or equivalent experience.
• Minimum of 10 years of experience 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 and timely deliverables.
• Background in project management, site leadership, or oversight of high-volume clinical trials strongly desired.
• Thorough understanding of Good Clinical Practices (GCP), Code of Federal Regulations (CFR), HIPAA, and ICH guidelines as they apply to clinical research.
• Experience with 21 CFR Part 11 and Computer System Validation (preferred but not required).
• Bilingual Spanish highly preferred.
• Strong analytical, organizational, and problem-solving skills with the ability to adapt in a dynamic environment.
• Excellent communication skills (interpersonal, written, and verbal) and documentation practices.
• Proficiency in Microsoft Word, Excel, and familiarity with clinical research systems (e.g., Clinical Trial Management Systems).
• Ability to travel as requested.

Published Category: Quality & Validation