Vice President, Global GMP Quality

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.

About the role

The VP, Global GMP Quality position will lead the GMP quality functional teams at Mirum and its subsidiaries (US and International). This role will steer the organization toward an ongoing commitment to quality improvement, driving efforts to identify areas for optimization, innovation, and excellence. The position involves managing, mentoring, and supporting a GMP Operations team of clinical and commercial Quality Assurance (QA) and Quality Control (QC) professionals, ensuring seamless execution of GMP QA and QC functions, including product quality complaint investigations, root-cause analyses, and reporting critical GMP issues to executive management.

This role ensures all GMP quality processes comply with FDA, EMA, and other international regulatory requirements, corporate objectives, and industry best practices. It also aligns GMP and GDP quality functions with the organization’s broader strategic goals, supporting Mirum’s mission, vision, and operational objectives.

Responsibilities

• Serve as the GMP quality strategic leader to assist the head of quality in developing a compliant, collaborative, and phase-appropriate quality culture at Mirum.
• Develop and execute a global GMP quality strategy aligned with corporate goals and regulatory requirements.
• Lead the GMP QA and QC functional teams, fostering professional development and guiding staff in GMP/GDP competence to meet domestic and international regulatory requirements (FDA, EMA, MHRA, NMPA, ICH, etc.).
• Drive 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, providing strategic leadership, interactions, responses, CAPA plans, and implementation.
• Lead GMP inspection readiness, including quality improvement and maintenance, and host/manage GMP PAI/PLI inspections at Mirum while supporting 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’s global organizations and subsidiaries.
• Promote collaboration across internal and external teams to identify, design, and implement opportunities for improvement in GMP and GDP quality responsibilities.
• Establish, maintain, and ensure the effectiveness of GMP and GDP quality programs and documentation to assure GxP compliance in domestic and international regulatory environments.
• Oversee, support, and perform all aspects of GMP QA and QC activities for drug manufacturing to ensure product quality and supply chain integrity.
• Oversee and support all aspects of clinical and commercial product release, including direct-to-market, partner, and distributor channels.
• Serve as the Material Review Board (MRB) chair-person designee.
• Develop and execute a global recall strategy integrating domestic and international recalls.
• Serve as the Recall Coordinator in the recall committee and support the recall/mock recall process.
• Collaborate with the Commercial Organization on launch strategies, NPP/EAP/CUP programs, and provide input as a Quality SME.
• Review and approve GMP, GDP, Partner, and Distributor Quality/Technical Agreements.
• Oversee the timely review and approval of Annual Product Quality Reviews (APQR).
• Assess outcomes of GMP audits at CMOs, CTLs, and Partners to drive improvements in partnership with the Technical Operations team.
• Provide strategic and managerial leadership related to company objectives, initiatives, and changing regulatory requirements to build, manage, and mentor high-performance QA and QC teams globally.
• Oversee product launch, manufacturing, and distribution quality processes.
• Lead a culture of quality excellence, compliance, and continuous improvement across the organization.
• Ensure the global GMP Quality Team meets stakeholder needs, focusing on efficiency, quality, budget management, and corporate growth.
• Serve as Quality Head designee for other GxP areas beyond GMP and GDP as required.

Requires a minimum of 15% domestic and international travel.

Qualifications

• Bachelor’s degree in biochemistry, chemistry, biology, or another science-related field (Advanced degree preferred).
• 15+ years of progressive Quality Assurance experience in pharmaceutical and/or biotech industries, with at least 10+ years in a quality leadership role and/or people management, including direct and indirect reports.
• Extensive knowledge of cGMP manufacturing and Quality Management in compliance with FDA (CBER and/or CDER) and EMA requirements for global-regulated products.
• Extensive knowledge of the development and commercialization of medical devices in compliance with FDA 21CFR820, ISO13485, and EMA MDR regulations.
• Comprehensive knowledge of GMP, GDP, ISO, ICH, and global regulatory requirements.
• Product lifecycle experience, including late-stage drug development, regulatory submissions (NDA, MAA, BLA, etc.), and commercial manufacturing.
• Experience hosting and preparing for inspection readiness, with the ability to provide recommendations for continuous improvement.
• Ability to work cross-functionally as a strong collaborator, partnering with internal and external stakeholders across multiple global regions.
• Experience managing Product Quality Complaints and Pharmacovigilance Quality is a plus.
• Experience in rare disease and/or biologics is a plus.

Skills

• Extensive hands-on experience in product lifecycle management, including late-phase innovative drug development, medical devices, combination products, and global commercial launch with global CMC regulatory filings (IND/IMPD/CTA/NDA/BLA/MAA, etc.) in a multinational pharmaceutical organization.
• Demonstrated project and cross-functional team leadership, as well as people management skills across different cultures.
• Thorough understanding and working experience in innovative drug development and manufacturing of drugs and biologics concerning GMP operations, quality systems, ICH guidelines, FDA, EMA, and associated international regulatory requirements.
• Extensive experience managing and overseeing analytical activities at CDMOs or CTLs with a quality mindset and leadership.
• Strong analytical and problem-solving skills with strategic and technically driven decision-making ability.
• Highly effective ability to influence and lead cross-functional teams.
• Strong sense of ethics and honesty.
• Ability to communicate with all levels of management and peers within the organization.
• Effective written and verbal communication skills and interpersonal skills.

Pay

The salary range for this position is $320,000 to $340,000 USD. Compensation will be determined based on several factors, including but not limited to skill set, years of experience, and geographic location. This range reflects base salary only and does not include bonus, equity, or benefits.