Director, Quality Compliance

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 – This position will be responsible for providing strategic leadership and oversight of the execution of the internal audit program including establishment and monitoring of appropriate trending and metrics to ensure compliance with global regulatory requirements including GMP, GCP, GVP, GDP, GLP, GCLP across Mirum functions and Mirum subsidiaries.

This position will provide oversight of assigned internal resource(s) and contract auditors in the execution of GMP, GDP, GCP, GVP, GLP, and GCLP audits. Responsibilities include supervising auditors, reviewing and approving audit reports, audit responses, and CAPAs, as well as supporting the establishment and reporting of audit metrics and trends, as applicable. 

Other responsibilities include supporting Mirum Inc. inspection readiness activities, leading Mirum Inc. inspection management activities, establishing a program for performing risk-based audits of regulatory submissions, coordinating Partner audits of Mirum, and assisting with other quality programs and initiatives as needed.

JOB FUNCTIONS/RESPONSIBILITIES

• Develop annual risk-based internal audit schedule for Mirum Inc. and Mirum Subsidiaries.
• Identify and secure appropriate audit resources for internal audits in alignment with budget.
• Ensure development of appropriate internal audit scope, agenda/ plan, and criteria.
• Oversee/facilitate audit execution and reporting of audit findings.
• Manage audit responses and CAPA in support of regulatory compliance and continuous improvements.
• Serve as the business owner for the Veeva QMS internal audits and inspection module (electronic system).
• Ensure that departmental processes and procedures related to internal audits are maintained in accordance with global regulations and guidance.
• Establish and report metrics related to internal audit processes.
• Serve as subject matter expert for internal audit program during audits and regulatory inspections.
• Provide training to organization related to internal audit program, regulatory/quality topics, and GMP, GCP, GVP, GLP, and GCLP requirements, as needed.
• Achieve established timelines and operate within budget.
• Supervisory responsibilities to include management of contract auditors and support personnel.

QUALIFICATIONS

Education/Experience:

• Bachelor’s degree required.  Bachelor’s degree or advanced degree in a scientific discipline preferred.
• 15 + years of experience in pharmaceuticals/biotechnology required, experience in Quality, or Regulatory functions preferred.
• Experience developing and managing a risk-based internal audit program for GxP compliance.
• Experience conducting internal or external audits according to GxP regulations required.
• Experience conducting GCP and GVP audits preferred.
• Experience in development of Quality systems and writing SOPs for clinical and commercial development phases.
• Experience in leading inspection readiness teams as well as experience hosting and managing regulatory inspections (FDA, EMA, MHRA, etc.).
• Must have thorough understanding of global GCP, GVP, GMP regulations.

Knowledge, Skills and Abilities:

• Professional demeanor and strong work ethic, commitment to quality, and sense of responsibility.
• Ability to work both independently and collaboratively in a team environment, with the ability to motivate and influence others.
• Excellent verbal and written communication skills.
• Ability to create and deliver in-person or virtual trainings or presentations on quality/regulatory topics, as needed.
• Must be process-oriented in support of pragmatic and sustainable regulatory compliance.
• Requires strong organizational skills to support prioritization of multiple projects/audits/ assignments.
• Proficiency with computer applications such as Word, Excel, Microsoft Teams/SharePoint and other electronic systems/platforms used in support of Quality management.
• Ability to understand and communicate in German or French a plus.
• Must be able to attend on site at Foster City, CA office as requested.
• Able to travel (up to 10% overnight travel).

#LI-HYBRID

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.