Vice President, Global GMP Quality

MISSION

Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.

The VP, Global GMP Quality position will be responsible for leading the GMP quality functional teams at Mirum and its subsidiaries (US and International). This position will play a pivotal role in steering the organization toward an ongoing commitment to quality improvement, driving efforts to identify areas for optimization, innovation, and excellence. This person will be responsible for managing, mentoring and supporting a GMP Operations team of clinical and commercial Quality Assurance (QA) and Quality Control (QC) professionals.

This person will provide leadership and hands-on support to ensure the seamless execution of GMP QA and QC functions, including product quality complaint investigation, root-cause investigations, and the reporting of critical GMP issues to executive management. This person will also be responsible for leading, providing direction, resources, and guidance to ensure that all GMP quality processes are executed with the highest standards of compliance with FDA, EMA, and other international regulatory requirements, corporate objectives, and industry best practices.

This role also involves ensuring that the GMP and GDP quality functions are closely aligned with the organization’s broader strategic goals, guaranteeing that quality initiatives support the company’s mission, vision, and operational objectives.

• Serve as the GMP quality strategic leader to assist the head of quality to further develop the quality culture at Mirum to be compliant, collaborative and phase appropriate.
• Develop and execute a global GMP quality strategy to align with corporate goals and regulatory requirements.
• Serve as the GMP quality strategic leader within the Quality group to lead the GMP QA and QC functional teams in fostering professional development and guiding staff in all aspects of GMP/GDP competence in meeting domestic and international regulatory requirements and guidelines (FDA, EMA, MHRA, NMPA, ICH, etc.).
• Lead the development and optimization of key processes, functional collaboration, transformational initiatives, and operational excellence through the GMP/GDP Quality Unit.
• Serve as the GMP quality lead in Audits and Regulatory Inspections in providing strategic leadership, interactions, responses, CAPA plans and implementation.
• Lead the GMP inspection readiness for the Company including GMP Quality improvement and maintenance.
• Host/Manage GMP PAI/PLI inspections at Mirum and support Mirum PAI/PLI related CMO inspections.
• Drive corporate values, vision, goals, and objectives through collaboration with senior leaders building cross-functional networks to influence operational capabilities.
• Serve as a GMP Quality advisor to cross-functional stakeholders within Mirum global organizations and subsidiaries.
• Promote collaboration across internal and external functional teams and stakeholders to identify, design and implement opportunities for improvement across all areas of GMP and GDP quality responsibilities.
• Establish, maintain, and ensure effectiveness of GMP and GDP quality programs and documentation to assure GxP compliance in the domestic and international regulatory environment.
• Oversee, support and perform all aspects of GMP QA and QC activities and functions for drug manufacturing to ensure product quality and supply chain integrity.
• Oversee and support all aspects of clinical and commercial product release which includes direct to market, partner and distributor.
• Serve as the Material Review Board (MRB) chair-person designee.
• Develop and execute a global recall strategy that integrates domestic and international recalls.
• Serve as the Recall Coordinator in the recall committee and support the recall/mock recall process.
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