Senior Auditor, Vendor Audit

TL;DR

Senior Auditor, Vendor Audit (GxP): Organizes and hosts vendor audits to support global operations with an accent on compliance, risk management, and vendor approval processes. Focus on managing complex audit activities, trending systemic issues, and implementing corrective actions.

Location: Preferred Central / Midwest (US). Part-time 6-month 1099 contractor opportunity.

Company

hirify.global helps biotech, medtech, and specialty pharma companies transform ideas into new medicines, devices, and diagnostics.

What you will do

• Organize and host vendor audits, including preparation of plans, checklists, reports, and certificates.
• Manage complex audit activities per the vendor audit schedule and maintain up-to-date approved vendor lists.
• Collaborate with operational teams to review vendor issues, trend systemic problems, and implement global corrective actions.
• Act as point of contact for vendor audit activities.
• Ensure compliance with internal controls by examining records, reports, practices, and documentation.
• Communicate findings through final reports and discussions with auditees.

Requirements

• Bachelor’s degree in Health or Life Sciences or equivalent experience.
• 5-8 years specialized GxP experience in auditing (vendor audits), or 8+ years relevant with 5+ years vendor audits.
• Ability to interpret controlled documentation like protocols, validation documents, manufacturing records.
• Experience reviewing databases, trial master files, investigator sites, study reports, vendors, manufacturers, batch records, device history files, laboratories, system validation.
• Knowledge of ICH Guidelines, FDA regulations, and other applicable laws.

Culture & Benefits

• Growth opportunities with skills development and flexibility for work-life balance.
• Your ideas influence work processes and your voice matters.
• Essential role in delivering medical innovation for patients.