Senior Quality Auditor

Role Summary

Senior Quality Auditor responsible for GCP/GLP/GCLP/GVP audits, drafting/reviewing audit reports, managing audit responses and CAPA, and supporting data collection, metrics, and eQMS maintenance 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’s 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