Director, GMP Quality Assurance Operations

Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are seeking an experienced Director, GMP Quality Assurance (QA) Operations to provide strategic and operational leadership in managing quality for outsourced manufacturing and testing operations, ensuring product quality, regulatory compliance, and reliable supply of clinical material.

Requirements

• Manage and provide oversight of routine operations conducted by external partners
• Provide timely feedback for GMP quality events and escalate to management for aligned decisions
• Ensure timely batch record review, product disposition, and compliance with regulatory requirements
• Develop and monitor partner performance metrics, risk assessments, and escalation pathways
• Collaborate with internal CMC, Regulatory, Quality Control, and Supply Chain teams to support technical transfers, process development, and regulatory submissions
• Serve as GMP SME for cross-functional initiatives to strengthen quality systems, enhance compliance, and drive operational efficiency
• Serve as a primary QA representative during regulatory inspections
• Own inspection follow-up activities, including CAPA development, execution, and effectiveness verification
• Champion a culture of quality and inspection readiness across internal and external operations