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/Sr. Director, GxP Quality & Safety Operations is a newly created position requiring a strong leader who will provide strategic and operational leadership, and who will ensure the effectiveness of the GxP Quality and Safety team. We are seeking a highly motivated, strategic GxP Quality leader who has experience with global clinical trials and in-depth knowledge of global regulations. The candidate should be able to provide expert ICH/GxP leadership, consultation, and direction to stakeholders regarding global GxP related activities/issues. The individual should have demonstrated success in leading inspection readiness activities and in hosting GxP global Health Authority inspections. The candidate should have the ability to identify and drive CAPAs and continuous process improvement initiatives through collaboration with their clinical counterpart. The candidate has a track record of creating and growing a compliant and efficient safety operations framework, partnering with CRO(s), ensuring support of our clinical program and future transformation to post-market safety requirements.
- Accountable for creating and implementing global inspection readiness strategy for the Company including a Quality Management System deployment.
- 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 development 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.
- Lead, develop and motivate a team of GxP Quality professionals.
- Accountable for developing the overall Medical Safety Operations road map to maintain compliance and data quality.
- Has direct management interactions with PV Operations CRO
- Post Approval Readiness for Medical Safety Operations
- Oversees the Safety Management Plans and set-up of safety systems.
- Oversees product complaints management between Safety and Quality Assurance
- Bachelor’s Degree in a scientific discipline.
- 15+ years of experience in the pharmaceutical industry, including 5+ 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 GxP regulations.
- Advanced knowledge in the conduct and reporting of Heath Authority inspections and the translation of findings into corrective action.
- Strong 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.
Please submit your resume to firstname.lastname@example.org