Senior Vendor Auditor

Job Summary

A company is looking for a Senior Auditor, Vendor Audit.

Key Responsibilities

• Organizes and hosts vendor audits, preparing audit plans, checklists, reports, and certificates
• Manages complex audit activities and maintains an updated approved vendor list for study-level use
• Collaborates with operational teams to address vendor issues and trends, ensuring corrective actions are implemented globally

Required Qualifications

• Bachelor's degree or equivalent in Health or Life Sciences, or relevant experience
• 5-8 years of specialized GxP experience in auditing, or 8+ years of relevant experience with 5+ years in vendor audits
• Ability to interpret controlled documentation, including protocols and validation documents
• Demonstrated ability to review databases, trial master files, and various regulatory documents independently
• Knowledge of ICH Guidelines and FDA regulations