Senior Auditor, Vendor Audit

Premier Research

1d • Remote

About The Position

Premier Research is looking for a Senior Auditor, Vendor Audit to join their Functional Services Provider (FSP) team. This role involves helping biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. The company emphasizes that its work is profoundly connected to saving and improving lives and values its team members as the most valuable asset. Premier Research aims to support employee growth, provide skills and opportunities for excellence, and offer flexibility and work-life balance. Employees' ideas and voices are valued, contributing to delivering medical innovation. Premier Research is described as a community dedicated to furthering research to improve patients' lives, with a diverse staff that thinks creatively, challenges ideas, and solves complex problems. The company's values are: We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care. Team members are empowered to make an impact. Premier Research is a global clinical research, product development, and consulting company focused on helping biotech, specialty pharma, and MedTech innovators. The company fosters an environment where employees can change lives, feel rewarded, and celebrated, driven by a common purpose and a commitment to continuous learning and innovative technologies.

Requirements

• 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

Responsibilities

• Organizes and hosts Vendor audits to support global operations (including preparation of 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; discussing findings with auditees.

What This Job Offers

• Job Type: Part-time
• Career Level: Senior
• Number of Employees: 251-500 employees