Director, GMP Quality Assurance
MISSION
Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.
POSITION SUMMARY
The Director, GMP Quality Assurance is responsible for the global oversight and management of GMP Quality Assurance operations supporting development and commercial programs.
The role manages multiple complex priorities, provides technical and compliance leadership, resolves quality issues, and collaborates cross-functionally with internal stakeholders and external partners to support product quality, regulatory compliance, and continuity of clinical and commercial supply.
The position also provides oversight of clinical and commercial Good Distribution Practice (GDP) activities, including compliance with applicable U.S., EU/UK, and other global GDP requirements including the U.S. DSCSA, serialization, track-and-trace, and exception management requirements. The Associate Director/Director is accountable for the quality and
