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Manager, Quality Systems and Vendor Management

Foster City



Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults. Propelled by our passion for patients and their families, we’re focused on turning possibilities into realities. Using data and meaningful evidence, our goal is to transform scientific discoveries into therapies that are poised to positively impact the treatment of rare diseases. 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. Learn more about our work, our culture, and what it’s like to be a part of our team: www.mirumpharma.com.




Manages activities involving GxP quality assurance and compliance with applicable regulatory requirements. Assists in the development of policies and procedures to ensure quality standards in compliance with relevant regulatory and quality guidelines. This position requires experience with global contract manufacturing organizations and knowledge of global GxP regulations. The incumbent provides strategic direction of Mirum’s Quality Management System to ensure execution and performance of the QMS in accordance with regulatory requirements and company objectives.


  • Assist with the overall management of Mirum’s GxP vendor qualification and audit program. Assist with audit scheduling, report reviews, tracking and trending vendor management activities and CAPA follow up.
  • Assist with the establishment of vendor performance KPIs and reporting structure.
  • Assist with the implementation of a Supplier Scorecard structure.
  • Assistance with the global Alliance Management qualification process.
  • Assistance with hosting and conducting Partner audits.
  • Ensures that the Quality Management System is maintained in accordance with current regulatory compliance requirements and meets company objectives.
  • Author quality policies and standard operating procedures, as needed.
  • Establish and oversee the processes for accurately tracking, reporting, and analyzing metrics, as required.
  • Assist with audits and regulatory inspections, as applicable.
  • Update/establish Quality/Technical Agreements with CMOs. Assist with the tracking of Quality Agreements.
  • Support GxP inspection readiness activities.
  • Other duties assigned, as needed.



  • Bachelor’s degree in a scientific discipline

Knowledge, Skills and Abilities:

  • 4-6 years’ experience and strong background in Quality and Quality Systems in the drug development industry with knowledge of GxP/ICH/FDA/EMA regulations.
  • Prior experience in QA with particular focus vendor management, auditing and supplier performance initiatives.
  • Experience with working in a global setting and a thorough understanding of international regulatory requirements.
  • Demonstrate a quality mindset and ability to influence across the organization.
  • Successful experience writing and reviewing SOPs and other Quality documents.
  • Expert knowledge of phase appropriate cGxPs and experience leading Quality System implementation and continuous improvement efforts.
  • Demonstrated ability to successfully interact with regulatory health authorities at inspections and thorough understanding of audit and vendor management programs.
  • Excellent organizational skills: Proactive, management of multiple tasks of varying complexity simultaneously.
  • Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment.
  • Experience with Veeva electronic quality management system is a plus.


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.