Senior Auditor (Vendor Audit)

TL;DR

Senior Auditor (Vendor Audit): Managing complex vendor audit activities to ensure global compliance with GxP standards and regulatory requirements. Focus on conducting independent audits, documenting systemic issues, and collaborating with operational teams to maintain high-quality standards in clinical and manufacturing environments.

Location: Must be based in the United States, with a preference for the Central or Midwest regions.

Company

A global clinical research organization helping biotech, medtech, and pharma companies transform breakthrough science into life-changing medical solutions.

What you will do

• Organize and host vendor audits, including preparation of audit plans, checklists, and final reports.
• Manage complex audit activities to ensure the approved vendor list remains current and compliant.
• Collaborate with operational teams to identify, trend, and document systemic vendor issues.
• Act as the primary point of contact for all vendor audit-related activities.
• Ensure compliance with internal control procedures by examining records, reports, and operating practices.
• Discuss audit findings with auditees and implement necessary corrective actions.

Requirements

• Must be a US-based contractor (1099).
• Bachelor’s degree in Health or Life Sciences or equivalent experience.
• 5-8 years of specialized GxP auditing experience, specifically in vendor audits.
• Demonstrated knowledge of ICH Guidelines, FDA Code of Federal Regulations, and applicable regulatory laws.
• Ability to interpret complex controlled documentation including protocols, validation documents, and manufacturing records.
• Proven ability to independently review databases, trial master files, and clinical study reports.

Culture & Benefits

• Opportunity to contribute to life-saving medical innovations.
• Flexible work environment that values individual ideas and professional growth.
• Part-time 6-month contract engagement.
• Inclusive culture committed to equal opportunity employment.