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 Sr. Manager of GMP Quality will be responsible for managing activities involving GMP operations and compliance with Mirum procedures and 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 providing quality oversite for global contract manufacturing organizations (CMO) and Contract Testing Labs (CTL) as well as knowledge of global GMP regulations for clinical and commercial product.
- Provide QA oversite of CMO manufacturing Drug substance, drug product and finished product for commercial and clinical use.
- Author and negotiate quality agreements for GMP vendors.
- Review and approve protocols and reports related to technology transfers, process validation and development.
- Works closely with the CMO to investigate, document, and resolve compliance issues and deviations. Ensure deviations are thoroughly identified, defined, and properly assessed.
- Perform or support vendor audits and write audit reports with findings, when necessary.
- Advise, review and approve master batch records and executed batch records and perform batch disposition for drug substance, drug product and finished product for commercial and clinical use.
- Develop, track and trend quality metrics for reporting.
- Review and approval of analytical methods, product specifications, product certificate of analysis, analytical method validation protocols and reports.
- Develop, advise, review and approve Quality Systems documents (procedures, specifications, protocols, deviations, change controls, CAPAs, etc.).
- Investigate, manage and approve product complaints reports for closure.
- Communicates manufacturing deficiencies and non-conformances to management and works with vendors to ensure timely resolutions.
- Stay abreast of changes in applicable FDA and European regulations, directives and guidelines and determine potential impact on company GMP activities.
- Assists in updating regulatory and quality documents (INDs, IMPDs, Annual Reports).
- Assists in hosting audits and regulatory inspections.
- Maintain flexibility to perform other / additional tasks as assigned.
- Must be capable and willing to travel (up to 15%), including international travel.
- Bachelor’s Degree in a scientific discipline.
- 8+ years of experience in the pharmaceutical industry, including 8+ years in GMP Quality Assurance.
- Knowledge and demonstrated experience in the applicable GMP regulations, FDA Regulations and Good Manufacturing Practices, EMA Eudralex Regulations, ICH Guidelines and Good Distribution Practices.
- Strong verbal and written communication.
- Strong influencing skills: proven ability to get things done.
- Ability to work effectively with cross-functional teams.
- Late stage drug development, Regulatory (NDA) submission and commercial manufacturing experience.
- Experience with inspection readiness process and able to provide recommendations for its continuous improvement.
To apply, please send your resume to email@example.com.