GxP Compliance Consultant

Job Summary

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

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 lifecycle 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