GxP Compliance Consultant

Job Summary

To support GxP compliance activities across Pharmacovigilance, Clinical, and Regulatory Affairs systems, the full-time remote GxP Compliance Consultant will provide subject matter expertise, develop validation deliverables, and ensure ongoing compliance with applicable regulations.

Key Responsibilities

• Provide CSA / CSV subject matter expertise across PV, Clinical, and Regulatory Affairs platforms
• Develop and review validation deliverables, including Validation Plans and Risk Assessments
• Conduct periodic system compliance reviews and assessments to ensure ongoing regulatory compliance

Required Qualifications

• 5-8 years of hands-on experience supporting GxP systems in Pharmacovigilance, Clinical, or Regulatory Affairs
• Strong understanding of CSA principles, CSV, and SDLC processes
• Experience authoring and/or reviewing validation documentation
• Working knowledge of GxP regulations (e.g., FDA, EMA, ICH) and data integrity expectations
• Ability to work independently in a fast-paced, matrixed environment