GCP Auditor

GxP Global Quality Network provides end-to-end compliance, quality, and regulatory services for pharmaceutical, biotechnology, and clinical research organizations. Our expertise supports clients throughout the entire product development lifecycle, ensuring global adherence to GxP standards, including GMP, GCP, GLP, and GVP. We help organizations identify risks and implement remediation strategies while meeting regulatory expectations across the U.S., EU, and Asia-Pacific regions. Our team is dedicated to driving excellence and delivering tailored guidance to enhance quality and compliance in the life sciences industry. Role Description The GCP Auditor will conduct Good Clinical Practice (GCP) audits of investigator sites, vendors, and internal systems to ensure regulatory compliance and quality standards. Responsibilities include preparing and performing audits, drafting audit reports, and performing CAPA reviews. Qualifications Experience in Good Clinical Practice (GCP) audits and regulatory compliance within the clinical research or pharmaceutical industry Strong analytical, risk assessment, and problem-solving skills to identify and address compliance gaps Excellent written and verbal communication skills, including preparation of comprehensive audit reports Time management and organizational skills to manage multiple audits and deadlines effectively Proficiency in understanding global clinical trial regulations, including FDA, EMA, and ICH-GCP guidelines Ability to collaborate effectively with cross-functional teams and stakeholders Bachelor’s degree in Life Sciences, or a related field; advanced degree or professional certification (e.g., RQAP-GCP) is a plus Prior experience in a quality assurance or clinical operations role is preferred Location: Maple Shade, NJ #J-18808-Ljbffr