Foster City

POSITION SUMMARY 

This position will be responsible for executing the internal audit program to ensure compliance with global regulatory requirements including cGMP, GCP, GPvP, GDP, GLP, GCLP across Mirum functions and Mirum subsidiaries.

Additionally, this position will support Mirum Inc. inspection readiness and inspection management activities, regulatory surveillance, and 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 in alignment with budget.
• Ensure development of appropriate audit scope, agenda/ plan, and criteria.
• Oversee/facilitate audit execution and reporting of audit findings.
• Manage audit responses and CAPA in support or regulatory compliance and continuous improvements.
• Serve as the business owner for the Veeva QMS 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, as need.
• Achieve established timelines and operate within budget.
• Supervisory responsibilities may include oversight of contract auditors and support personnel.

QUALIFICATIONS

Education/Experience:

• Bachelor’s or advanced degree in a scientific discipline.
• 10 + years of experience in Quality or Regulatory in pharmaceuticals/biotechnology.
• Requires experience in application of GCP, GPvP, GMP, and other GxPs to functional processes / systems.
• Requires experience in development of Quality systems 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.) highly desired.
• Must have thorough understanding of global GCP, GPvP, GMP regulations.

Knowledge, Skills and Abilities:

• Must have professional demeanor and demonstrate a strong work ethic, commitment to quality, and sense of responsibility.
• Requires ability to work both independently and collaboratively in a team environment, with the ability to motivate and influence others.
• Requires excellent verbal, written, and interpersonal communication skills.
• Must have ability to create and deliver in-person or virtual training 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.
• Able to travel (up to 10% overnight travel).

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