Senior Auditor, Vendor Audit

Premier Research is looking for a Senior Auditor, Vendor Audit to join our Functional Services Provider (FSP) team. You will help biotech, medtech, and specialty pharma companies transform life‑changing ideas and breakthrough science into new medicines, devices, and diagnostics.

As an essential part of our team, you will organize and host Vendor audits to support global operations. This includes preparing audit plans, audit checklists, audit reports and certificates.

• Manages complex audit activities in accordance with the Premier Research Vendor audit schedule and ensures the approved vendor list remains up to date and that only approved vendors are listed as available for use at a study level.
• Collaborates with operational teams to ensure any documented Vendor issues and/or gaps raised at a study level are reviewed on an ongoing basis and trended for potential systemic issues.
• Any systemic issues are formally documented, and corrective actions implemented at a global level (to include contracts, etc. as appropriate).
• Acts as Point of Contact (POC) for vendor audit activities.
• Ensures compliance with established internal control procedures by examining records, reports, operating practices, and documentation.
• Communicates audit findings by preparing a final report and discussing findings with auditees.

• Bachelor’s degree, or international equivalent from an accredited institution, in Health or Life Sciences, or equivalent experience.
• 5–8 years specialized GxP experience in auditing (i.e., vendor audits), or 8+ years relevant experience with 5+ years’ experience conducting Vendor audits.
• Ability to interpret controlled documentation (i.e., protocols, validation documents, manufacturing records and data).
• Demonstrated ability to independently review the majority of the following: databases, trial master files, investigator sites, statistical/clinical study reports, vendors, manufacturers, master batch records, device history files, laboratories, system validation documentation.
• Demonstrated knowledge of ICH Guidelines, FDA Code of Federal Regulations and other applicable regulatory authority laws and regulations.

Preferred

Location:

Central / Midwest.

Part‑time 6‑month 1099 contractor opportunity.

Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The actual salary will be influenced based on a variety of factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.

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.