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 Executive Director/ Vice President, Quality is a newly created position requiring a strong leader who will provide strategic and operational leadership, and who will ensure the effectiveness of the Quality team. A highly motivated, strategic Quality leader who has experience with global clinical trials and commercial supply, with in-depth knowledge of global regulations. The candidate should be able to provide expert ICH/GxP leadership, consultation, and direction to the Quality team and stakeholders regarding Quality related activities/issues. The individual should have demonstrated success in preparing and leading agency inspections. The incumbent maintains oversight of the Quality System, internal and external audit cycles, vendor oversight programs, GxP metrics, leads the Quality Management Committee drive CAPAs and continuous process improvement initiatives through collaboration with their functional counterparts including clinical operations, CMC, commercial and supply chain.
- Accountable for creating and implementing global inspection readiness strategy for the Company including Quality Management System maintenance.
- Ensuring Mirum Executive Leadership are informed of new risks or concerns, in a timely manner, that may impact purity, quality, potency or safety of clinical and commercial products.
- Proactively identify and make plans for remediation for areas of risk or improvement.
- Identify inspection readiness goals, collaborate with cross-functional leaders to champion the process, collaborate with cross-functional leaders to identify and implement operational oversight and quality activities within clinical and CMC functions in support of global inspection readiness.
- Lead GxP global inspections, response strategy and development and execution of resulting CAPA plans.
- Provide ICH/GxP expertise and consultative guidance related to business initiatives and lead GxP Quality initiatives involving systems, processes, procedures, regulations, and tools intended for use in clinical trial conduct and/or regulated drug development activities.
- Establish Quality Vendor Oversight Program and establish relationships with CRO Quality Team members for the ongoing review of quality and compliance metrics and issues.
- Maintain a high level of expertise in global GxP regulations and internal policies and procedures that may impact clinical development and Commercial supply.
- Lead, develop and motivate a team of GxP Quality professionals who are responsible for Quality in clinical, CMC, laboratory, document control, IT systems and training.
- Chairs the Quality Management Committee reporting key findings quarterly to the Executive Leadership of Mirum.
- Bachelor’s Degree in a scientific discipline.
- 15+ years of experience in the pharmaceutical industry, including 10+ years in GxP Quality or adjacent Safety/Clinical compliance teams.
- Advanced knowledge and demonstrated experience in the applicable GXP regulations, FDA Good Clinical Practices, ICH Guidelines, and Global Drug Development Regulations and Guidance.
- In-depth knowledge of drug development processes and must include both GMP and GCP regulatory experience.
- Advanced knowledge in the conduct and reporting of Heath Authority inspections and the translation of findings into corrective actions.
- Ability to build and manage relationships with business partners.
- Ability to work under deadline pressure, and to effectively manage multiple projects and rapidly shifting priorities.
- Solution orientated with analytical thinking and problem-solving skills.
- Ability to multi-task in a very fast-paced environment.
- Excellent verbal and written communication.
- This is a high growth, fast paced small, international organization. The ability to be productive and successful in this type of work environment is critical.
- Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be 10-15% of work time.
To apply, please send your resume to firstname.lastname@example.org.