SVP Quality Assurance Compliance

Job Summary

A company is looking for a Senior Vice President of Quality Assurance and Compliance.

Key Responsibilities

• Lead and enhance the enterprise-wide GxP Quality Management System, ensuring compliance across GMP, GLP, and GCP domains
• Drive inspection readiness and prepare for FDA CVM Pre-Approval Inspections (PAIs) and other regulatory inspections
• Oversee GCP quality systems, GMP compliance across CMC development, and lead audits and quality agreements with vendors

Required Qualifications & Experience

• 20+ years of Quality Assurance leadership experience in regulated pharmaceutical or animal health environments
• Proven success in leading organizations through FDA regulatory inspections with favorable outcomes
• Experience in designing and implementing enterprise-wide GxP Quality Management Systems in high-growth environments
• Deep expertise in GMP, GCP, and GLP quality systems, including oversight of clinical and manufacturing vendors
• Demonstrated ability to build and mentor high-performing QA teams in dynamic organizations