Vice President, Global GMP Quality

The posting, as Mirum Pharmaceuticals wrote it

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.

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, 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.

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.).
• 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 cor

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tional pharmaceutical organization.

• Demonstrate 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 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 effective 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.

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 the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

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Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran’s status or any other classification protected by applicable State/Federal/Local laws.

Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.