Foster City

POSITION SUMMARY

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 a GMP Operations team of clinical and commercial Quality Assurance (QA) and Quality Control (QC) professionals.  This person will also be responsible for leading, providing direction, resources, and guidance to ensure that all 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.

JOB FUNCTIONS/RESPONSIBILITIES

• 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.).
• Serve as the GMP quality lead for driving continuous process improvements.
• 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.
• Provide guidance and assistance to the team for the Regional Inspection Management process.
• Host/Manage GMP PAI inspections at Mirum and support Mirum PAI related CMO inspections.
• Interface with regulatory agencies as required and participate in regulatory authority inspections.
• 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 all aspects of GMP QA and QC activities and functions for drug manufacturing to ensure product quality and supply chain integrity.
• Oversee all aspects of clinical and commercial product release which includes, direct to market, partner and distributor.
• Serve as the Material Review Board (MBR) chair-person designee.
• Serve as the Recall Coordinator in the recall committee and support the recall process.
• Collaborate with Commercial International on launch strategies and provide input as a Quality SME.
• Review and approval of GMP, GDP, Partner and Distributor Quality/Technical Agreements
• Oversee the review and approval of APQR generation in a timely fashion.
• Assess the outcome of GMP audits at CMOs, CTLs, Partners, etc. for a holistic view and to partner with the Technical Operations team in driving improvements.
• Requires 15% domestic and international travel, at minimum.
• 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 in a global environment.
• Oversee product launch, manufacturing, and distribution quality processes.
• Lead a culture of quality excellence, compliance, and continuous improvement across the organization.
• Ensure global GMP Quality Team meets stakeholder needs, focusing on efficiency, quality, budget management, profitability, and corporate growth.

QUALIFICATIONS

Education/Experience:

• Bachelor’s degree in biochemistry, chemistry, biology, or other science related field (Advanced degree preferred).
• 15+ years of Quality Assurance experience in pharmaceutical and/or Biotech industries, with at least 10+ years in quality leadership role and/or people management including direct & indirect reports.
• Demonstrates extensive knowledge of GMP manufacturing and Quality Management for FDA (CBER or CDER) or EMA or global-regulated products.
• Comprehensive knowledge of GMP, GDP, ICH, and global regulatory requirements.
• Product lifecycle including Late-stage drug development, Regulatory (NDA) submission and commercial manufacturing experience.
• Experience with inspection readiness and an ability to provide recommendations for its continuous improvement.
• Experience in rare disease and/or biologics, a plus.

Knowledge, Skills and Abilities:

• Extensive experience in product lifecycle including late-phase innovative drug development and global commercial launch with global CMC regulatory filings (IND/NDA/MAA, etc.)
• Demonstrate project and cross-functional team leadership, as well as people management skills.
• Thorough understanding and working experience in innovative drug development and manufacturing concerning GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements.
• Extensive working experience with management and oversight of the analytical activities at CDMOs or CTLs with quality mind-set and leadership.
• Strong analytical and problem-solving skills with strategic and sound technically driven decision-making ability.
• Highly diplomatic and strong 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.

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