GCP Quality Assurance Director

GCP Director of Quality Assurance and Compliance

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).

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