Senior GCP Auditor

Maintain and update the Clinical Trial Quality Management System Contribute to development and review of SOPs and controlled documents Ensure compliance with SOPs, ICH GCP E6 (R2), regulations, guidelines, and clinical study protocols Manage incident management programs covering complaints, deviations, and CAPAs Schedule, plan, coordinate, and conduct vendor, supplier, internal, compliance, for-cause, and clinical trial site audits Prepare audit plans, reports, certificates, and corrective action plans Validate audit findings and follow-up activities to resolve non-compliance issues Review final audit documents for accuracy Review trial-related documents including protocols, amendments, ICFs, pharmacy manuals, and CSRs Apply regulatory, guidance, and protocol requirements to clinical trials Participate in resolving GCP compliance issues across Quality Assurance, Clinical Operations, Regulatory Affairs, Medical Affairs, and Pharmacovigilance Support training on company procedures, GCP regulations, and documentation systems Maintain QA spreadsheets tracking deviations, CAPAs, complaints, audit findings, and audit files Lead inspection-readiness development and implementation Assist senior staff during regulatory inspections and audits Represent QA at internal and external meetings supporting clinical programs Perform ad-hoc and cross-functional duties and projects Requirements Bachelor’s Degree in a life sciences or engineering discipline with a minimum of 7 years of experience in a GCP-Biologics or Pharmaceutical environment; or Master’s degree in a life sciences or engineering discipline with a minimum of 4 years of experience in a GCP-Biologics or Pharmaceutical environment Knowledge of and ability to apply ICH GCP E6 (R2) Understanding and application of ICH GCP E6 (R2) Strong problem solving and analytical skills Detail-oriented ability while managing multiple projects simultaneously Proficient verbal and written communication Ability to multitask across multiple functional areas Timeline-focused and flexible work scheduling Ability to plan and organize work activities and prioritize task completion CQA or other audit certifications preferred Prior TMF or electronic document management systems experience preferred Flexibility to work off-hours, second shift, and weekends Ability to travel 25%-30% Core Competencies Demonstrates expertise in Clinical Trial Quality Management, ensuring compliance with ICH GCP E6 (R2) and managing audit processes. Proficient in developing SOPs, conducting audits, and applying regulatory requirements to clinical trials. Highest-signal resume keywords ICH GCP E6 (R2) Compliance Clinical Trial Auditing SOP Development Incident Management CQA Certification ATS Optimization Keywords Hard Skills Clinical Trial Quality Management SOP Development Audit Planning Regulatory Compliance Incident Management Data Analysis Document Review Corrective Action Plans Quality Assurance Project Management Soft Skills Problem Solving Analytical Skills Detail-Oriented Verbal Communication Written Communication Certifications & Qualifications CQA Certification Industry Keywords GCP-Biologics Pharmaceutical Environment Regulatory Affairs Clinical Operations Pharmacovigilance Tools & Technologies TMF Systems Electronic Document Management Systems QA Spreadsheets #J-18808-Ljbffr