MISSION
Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.
POSITION SUMMARY
The position will serve as the primary auditor for GCP/GLP/GCLP/GVP audits. Further this position will draft, review and approve audit reports as well as managing audit responses and CAPA, as applicable. This position will assist with collecting data, establishing metrics, and performing tracking and trending of audit activities, and supporting the vendor audit management program. The position will be responsible for contributing to applicable SOP revisions for the Quality Compliance team and assist with the maintenance of the eQMS system as it relates to audit management as applicable.
JOB FUNCTIONS/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’ 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.
The salary range for this position is $190,000 to $200,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.
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Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran’s status or any other classification protected by applicable State/Federal/Local laws.
Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.
Top Skills
What We Do
Mirum Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. Mirum’s approved medication is LIVMARLI® (maralixibat) oral solution which is approved in the U.S. for the treatment of cholestatic pruritus in patients with Alagille syndrome one year of age and older.
Mirum’s late-stage pipeline includes two investigational treatments for debilitating liver diseases affecting children and adults. Maralixibat (LIVMARLI), an oral ileal bile acid transporter (IBAT) inhibitor, is currently being evaluated in clinical trials for pediatric liver diseases and includes the MARCH Phase 3 study for progressive familial intrahepatic cholestasis (PFIC) and the EMBARK Phase 2b study for patients with biliary atresia. In addition, Mirum has an expanded access program open in Canada, Australia, the UK and several countries in Europe for eligible patients with Alagille syndrome.
Mirum has submitted a Marketing Authorization Application to the European Medicines Agency for maralixibat for the treatment of cholestatic liver disease in patients with Alagille syndrome.
Mirum’s second investigational treatment, volixibat, also an oral IBAT inhibitor, is being evaluated in three potentially registrational studies including the OHANA Phase 2b study for pregnant women with intrahepatic cholestasis of pregnancy, VISTAS Phase 2b study for adults with primary sclerosing cholangitis, and the VANTAGE Phase 2b study for primary biliary cholangitis.
