Director, Quality Compliance

POSITION SUMMARY

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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 :

Knowledge, Skills and Abilities :

LI-Onsite

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