Associate Director, GCP QA

Mirum Pharmaceuticals(11 days ago)

HybridFull TimeSenior$190,000 - $205,000Quality Assurance

About this role

The Associate Director of GCP/GVP/GLP-QA at Mirum Pharmaceuticals oversees quality assurance activities related to clinical study programs, ensuring compliance with regulatory standards and industry practices. They support inspection readiness, internal and external audits, vendor management, and training, playing a critical role in maintaining data integrity and regulatory compliance.

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Required Skills

GCP
GVP
GLP
Regulatory Compliance
Audit
Vendor Management
Quality Assurance
ICH Guidelines
FDA Regulations
CAPA

Qualifications

Bachelor’s Degree in a scientific discipline
10-12 years of experience in the pharmaceutical industry
Knowledge of GCP, GVP, GLP regulations
Experience supervising GCP staff or consultants

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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