Senior GxP Compliance Audit Manager

Job Summary

A pharmaceutical company is seeking a Senior GxP Compliance Audit Manager.

Position Responsibilities

• Prepare and lead complex audits across GLP and GCP operations, including internal sites and third parties (domestic and international)
• Conduct GCLP audits of non-clinical and clinical study reports, central and specialty laboratories (CLIA and CAP)
• Lead pre-audit meetings with internal stakeholders to determine current vendor status and review pre-audit documentation

Required Qualifications

• Bachelor's Degree with a life science focus, Advanced Degree (Masters) in a scientific discipline a plus
• Extensive knowledge of GCP/GLP regulations with 10+ years of experience within a regulated healthcare industry
• Professional certification such as RQAP-GLP (Registered Quality Assurance Professional-GLP) or ASQ-CQA (American Society of Quality - Certified Quality Auditor)
• Working knowledge of FDA Regulations, EU GLP, and local country regulations
• Able to work independently and be flexible to changing priorities