SlipstreamJobs tracks this role from the company's public career site. Apply directly on the employer's site.
Mirum Pharmaceuticals seeks a Vice President of Global GMP Quality to lead quality operations across the organization and its international subsidiaries. This is a strategic leadership role managing teams of Quality Assurance (QA) and Quality Control (QC) professionals responsible for clinical and commercial product quality.
Key responsibilities include developing and executing a global GMP (Good Manufacturing Practice) quality strategy aligned with corporate goals and FDA, EMA, and international regulatory requirements. The VP will lead GMP QA/QC functional teams, fostering professional development and ensuring compliance with domestic and international standards (FDA, EMA, MHRA, NMPA, ICH guidelines).
The role encompasses oversight of critical quality functions: product quality complaint investigations, root-cause analysis, regulatory inspection readiness, and GMP audit leadership. The VP will serve as the GMP quality strategic advisor to cross-functional stakeholders, driving quality improvement initiatives and operational excellence across the organization.
Additional responsibilities include chairing the Material Review Board, developing global recall strategies, overseeing product release processes (direct-to-market, partner, and distributor channels), and reviewing quality/technical agreements with partners and distributors. The VP will collaborate with Commercial teams on launch strategies and provide quality subject matter expertise for new product programs.
This position requires hands-on support in executing GMP QA/QC functions while building and mentoring high-performance teams in a global environment. The VP will promote a culture of quality excellence, compliance, and continuous improvement, ensuring the team meets stakeholder needs with focus on efficiency, quality, budget management, and corporate growth.
