Vice President, Global GMP Quality

Role: Vice President, Global GMP Quality at Mirum Pharmaceuticals, leading worldwide GMP QA and QC functions for clinical and commercial products, ensuring compliance with international regulatory standards. Responsibilities: develop and execute global GMP quality strategies; oversee GMP QA/QC operations, product release, audits, inspections, and regulatory readiness; lead quality culture initiatives; collaborate across functions on product launches, recalls, and quality systems; mentor and manage senior QA/QC teams; support complex manufacturing and supply chain quality processes. Requirements: Bachelor's in science; 15+ years in pharmaceutical/biotech QA with 10+ years in leadership, extensive GMP knowledge (FDA, EMA, ICH), experience in late-stage drug development, product lifecycle management, and global regulatory filings. Preferred: experience with rare diseases, biologics, medical devices, and pharmacovigilance quality. High-Value: global GMP leadership, regulatory inspection management, cross-functional collaboration, biologics/rare disease expertise, international travel (~15%), senior-level strategic and operational oversight.