Senior Quality Auditor

Role Summary

Senior Quality Auditor responsible for leading GCP/GLP/GCLP/GVP audits, drafting and approving audit reports, managing audit responses and CAPA, and supporting data tracking, metrics, and vendor audit management. Contributes to SOP revisions and maintenance of the eQMS related to audit management.

Responsibilities

• Act as Quality Auditor Lead on GCP/GLP/GCLP/GPV Audits by performing Internal and External Vendor Audits as scheduled
• Support development of audit management plans and audit strategy for ongoing Internal and Vendor Audits
• Report audit findings to management with recommendations for resolution and verify appropriate corrective actions have been implemented/documented
• Support or conduct training for staff (GCP, GLP, GCLP, GPV)
• Support both Regulatory Inspections and Partner Audits of Mirum as needed
• Review/revise Standard Operating Procedure (SOPs) and procedures as assigned
• Support the day-to-day activities of the audit programs, including but not limited to audit coordinating, report reviews, response review, CAPA follow-up, and audit close-out as needed
• Gather data for accurately tracking, reporting, and analyzing metrics, as required
• Supports GxP inspection readiness activities, as applicable
• Other Duties as assigned

Qualifications

Education/Experience

• Bachelor‚Äôs degree in a scientific discipline

Knowledge, Skills And Abilities

• Minimum 10 years‚Äô experience in Quality Audits and/or experience in supporting GCP/GLP/GPV/GCLP audits and activities in the drug development industry with knowledge of FDA, EMA, MHRA and other applicable global regulations. Experience with other GxP (GMP, GDP) audits and regulations is a plus.
• Excellent verbal and written communication skills
• Demonstrated ability to influence across the organization
• Successful experience writing and reviewing SOPs and other Quality documents
• Thorough understanding of quality systems that support internal GxP activities for pre-clinical, clinical and commercial products
• Demonstrated ability to successfully interact with regulatory health authorities during inspections
• Thorough understanding of audit programs
• Excellent organizational skills with ability to manage multiple tasks of varying complexity simultaneously
• Strong interpersonal skills including relationship building, and conflict resolution
• Experience with Veeva platform systems is a plus
• Ability and willingness to Travel Domestically and Internationally up to 40 to 50% of time

Education

• Bachelor‚Äôs degree in a scientific discipline