Mirum focuses on finding and developing drugs for difficult to treat liver diseases. Our programs are focused on cholestatic liver diseases in children and adults. Our drug candidates, maralixibat and volixibat, target the bile acid accumulation from cholestasis, and we believe our approach can address the underlying cause of symptoms, liver damage, and clinical outcomes. Our goal is to give families their lives back.
The Director Quality, GxP Vendor and Compliance Management is responsible for developing a 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 and manage Mirum’s GxP vendor qualification and management program.
- Update and manage Mirum’s GMP/GLP audit program.
- Update and oversee GMP-impacting quality management systems, including change control, product complaints, deviations, and CAPAs.
- Update/establish Quality/Technical Agreements with CMOs.
- Lead GMP global inspection readiness activities and support GCP and GVP inspection readiness.
- 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.
- Knowledge of GCP regulations is helpful but not required.
To apply, please send your resume to firstname.lastname@example.org.