Manager, CSV Auditing

Job Summary

A company is looking for a Manager, Computer System Validation (CSV) Auditing.

Key Responsibilities

• Schedule, prepare, conduct, report, and follow up on routine and directed CSV audits globally
• Support other GxP audits as a CSV subject matter expert
• Guide and train team members while interpreting policies and evaluating compliance issues

Required Qualifications

• Bachelor's degree required; Master's degree preferred
• 6+ years of relevant experience with 4+ years of direct CSV/IT audit experience preferred
• In-depth knowledge of GxP regulations and international regulations
• Experience with FDA and EU regulations and ICH guidance documents
• Ability to work autonomously and manage complex projects