Mirum Pharmaceuticals, Inc. · 1 day ago
Senior Quality Auditor
Foster City, CA
Full-time
Hybrid
Senior Level, Lead/Staff
$190K/yr - $200K/yr
10+ years expMirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. The Senior Quality Auditor will serve as the primary auditor for GCP/GLP/GCLP/GVP audits, manage audit responses, and support the vendor audit management program.
BiotechnologyHealth CarePharmaceuticalTherapeutics
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
Qualification
Required
Bachelor's degree in a scientific discipline
Minimum 10 years' 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
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
Ability and willingness to Travel Domestically and Internationally up to 40 to 50% of time
Preferred
Experience with other GxP (GMP, GDP) audits and regulations is a plus
Experience with Veeva platform systems is a plus
Company
Mirum Pharmaceuticals, Inc.
Mirum Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults.
201-500 employees
H1B Sponsorship
Mirum Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (2)
2023 (1)
2022 (1)
2021 (1)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$765.5MKey Investors
TCG CrossoverOberland CapitalNew Enterprise Associates
2025-12-19Post Ipo Equity· $68.5M
2025-12-08Post Ipo Equity· $200M
2023-04-12Post Ipo Equity· $275M
Leadership Team
Joanne Quan
Chief Medical Officer
Recent News
Labiotech UG
2026-01-08
2026-01-03
Company data provided by crunchbase