Senior Auditor, Vendor Audit (contract)

Senior Auditor, Vendor Audit (contract) Premier Research is looking for a Senior Auditor, Vendor Audit (contract) to join our Functional Services Provider (FSP) team. This role focuses on supporting global operations in biotech, medtech, and specialty pharma companies. Responsibilities Organizes and hosts Vendor audits, including preparation of audit plans, checklists, reports, and certificates. Manages complex audit activities per the Premier Research Vendor audit schedule, ensuring the approved vendor list is current and only approved vendors are used at a study level. Collaborates with operational teams to review and trend documented Vendor issues or gaps at a study level for potential systemic issues. Documents any systemic issues and implements corrective actions at a global level, including contracts as appropriate. Acts as the point of contact (POC) for vendor audit activities. Ensures compliance with internal control procedures by examining records, reports, operating practices, and documentation. Communicates audit findings by preparing a final report and discussing findings with auditees. Qualifications Bachelor’s degree, or international equivalent from an accredited institution, in Health or Life Sciences, or equivalent experience. 5‑8 years of specialized GxP auditing experience (vendor, GCP, GMP audits), or 8+ years of relevant experience with 5+ years of vendor audit experience. Ability to interpret controlled documentation such as protocols, validation documents, and manufacturing records. Ability to independently review databases, trial master files, investigator sites, statistical/clinical study reports, vendors, manufacturers, master batch records, device history files, laboratories, and system validation documentation. Knowledge of ICH Guidelines, FDA Code of Federal Regulations, and other applicable regulatory authority laws and regulations. Preferred location: East Coast. Contract Details – Part‑time 6‑month 1099 contractor opportunity. Compensation – Starting hourly rate of $70/hr USD, with actual hourly rate influenced by qualifications, skills, competencies, and proficiency for the role. Equal Opportunity Statement – Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability, or veteran status. #J-18808-Ljbffr 11 Premier Research International LLC