Director, GMP Quality Assurance Operations

Mirum Pharmaceuticals(3 days ago)

HybridFull TimeSenior$220,000 - $235,000Quality Assurance

About this role

Mirum Pharmaceuticals is seeking an experienced Director, GMP Quality Assurance (QA) Operations to lead quality management in outsourced manufacturing and testing operations, ensuring product quality, regulatory compliance, and a reliable supply of clinical material. The role involves collaborating with multiple teams and managing external partners to uphold quality standards and support regulatory inspections.

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Required Skills

GMP
Quality Assurance
Regulatory Compliance
FDA
EMA
CQMP
Quality Systems
Inspection
CAPA
Biologics

About Mirum Pharmaceuticals

mirumpharma.com

Mirum Pharmaceuticals is a biopharmaceutical company focused on developing transformative medicines for rare liver diseases. It develops and commercializes therapies targeting cholestatic and pediatric liver disorders, notably maralixibat (Livmarli), which is approved to treat cholestatic pruritus in patients with Alagille syndrome, and is advancing programs for other inherited cholestatic conditions such as PFIC. Mirum emphasizes patient-focused clinical development and regulatory engagement to bring treatments that reduce symptoms, improve liver function, and enhance quality of life for affected children and families.

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