Mirum focuses on finding and developing drugs for difficult to treat liver diseases. Our lead program is focused on two severe liver diseases in children, Alagille syndrome and progressive familial intrahepatic cholestasis (PFIC). Both conditions can result in severe itching, liver damage and a need for liver transplant. Based on a wealth of data from clinical trials spanning multiple years and involving more than one hundred patients, we believe our approach can address the underlying cause of symptoms and liver damage. Our goal is to give families their lives back.
The Director of GMP Quality is responsible developing strategy for and managing activities involving GMP quality assurance and compliance with applicable regulatory requirements; development and implementation of policies and procedures to ensure quality standards in compliance with relevant regulatory and quality guidelines.
This position requires experience with global contract manufacturing organizations and knowledge of global GMP regulations. This position is responsible for identifying and driving CAPAs and continuous process improvement initiatives through collaboration with their CMC counterpart.
- Update/establish and oversee GMP-impacting quality management systems, to include change control, product complaints, deviations and CAPAs.
- Update and oversee clinical and commercial batch review/disposition process.
- Manage QA’s support of clinical and commercial method and process validation.
- Manage QA’s support of Mirum’s investigational product stability program.
- Update/establish Quality/Technical Agreements with CMOs.
- Support Mirum’s GMP vendor management/audit program.
- Lead GMP global inspection readiness activities.
- Work with QA head to manage global GMP PAI inspections at Mirum and support Mirum IP-related CMO inspections.
- Supervise QA staff.
- Bachelor’s Degree in a scientific discipline.
- 15+ years of experience in the pharmaceutical industry, including 10+ years in GMP Quality and 5+ years supervising GMP Quality staff.
- Knowledge and demonstrated experience in the applicable GMP regulations, FDA Regulations and Good Manufacturing Practices, EMA Eudralex Regulations, and ICH Guidelines.
- Strong verbal and written communication.
To apply, please send your resume to email@example.com.