GCP Auditor Position Available In Durham, North Carolina

The Opportunity The GCP Auditor will be the driving force behind the execution and maintenance of our Quality Management System (QMS). You’ll play a critical role in ensuring audit and inspection readiness, partnering with clients to deliver top-tier QA solutions with precision and confidence. Your expertise won’t just maintain standards; it will elevate them! What you’ll be doing: Deliver high-quality, on-time QA deliverables with precision and accountability Partner with the department manager to report on QA activities and key performance metrics Own and manage assigned sections of the Quality Document Management System (QDMS) to ensure compliance and accuracy Plan and execute core clinical trial audits (TMF, Site, Vendor, and Process) for both internal teams and external clients Keep the Quality Master Activities Plan (QMAP) and Vendor Master Activities Plan (VMAP) accurate, up-to-date, and audit-ready Serve as a QA lead on CAPA plans,guiding development, execution, and closure in line with SOPs Lead (or support) sponsor audits, including pre-audit preparation and crafting thorough, timely responses to findings Conduct targeted study document reviews (e.g., Trial Data Intelligence, study plans, etc.) and deliver clear, actionable reports Host or support key governance meetings Develop and deliver GCP training materials Support business growth by executing assigned external QA projects with a client-focused mindset Maintain 100% compliance with GCP guidelines and internal training requirements What we are looking for in a candidate Bachelor’s degree in Risk Management or a related field 3+ years of hands-on clinical trial auditing experience Comfortable navigating Microsoft Programs Expertise in FDA regulations, ICH guidelines, Good Clinical Practices (GCP), and regulatory submissions Solid grasp of quality systems, QA frameworks, and compliance standards Proven experience preparing for and managing high-stakes sponsor audits Working knowledge of FDA inspections and Bioresearch Monitoring Program (BIMO) manuals (7348.810 and 7348.811) Working knowledge of the TMF A sharp, analytical mindset with a talent for creative problem-solving and critical thinking Excellent communicator, both written and verbal Strong attention to detail and organizational skills Good technical writing ability Willingness and ability to travel up to 30%, domestically and internationally Aperio Clinical Outcomes provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.