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 Associate Director of GCP/GVP/GLP-QA is responsible for supporting Mirum’s clinical study programs as the GCP-QA representative on the study management team; managing activities involving GCP quality assurance and compliance with applicable regulatory requirements; development and implementation of policies and procedures to ensure quality standards in compliance with relevant regulatory and quality guidelines. Additionally, this position will support GVP and GLP QA operational activities to ensure data integrity and meeting regulatory expectations and industry standards.
This position requires experience with global contract research organizations (CROs) and GCP Vendors as well as knowledge of global GCP regulations.
JOB FUNCTIONS/RESPONSIBILITIES
- Achieve established timelines for deliverables.
- QA Representative for assigned Mirum’s Program’s Clinical Study Management Teams.
- Manage/Support BIMO inspection readiness activities
- Support GCP/GCLP/GVP internal audits.
- Provide quality oversite for the GCP/GVP/GLP vendor activities, including internal/external deviations, CAPAs, change controls, and KPIs/KQIs.
- Support GCP, GCLP and GVP Vendor Management/Audit Program. Ad hoc audits may be requested.
- Assist with planning and supporting Clinical Site Management/Audit Program. Ad hoc site audits may be requested.
- Assist with and support regulatory agency inspections for the GCP and PV impacted functions.
- Provide GCP/GCLP/GVP Training as necessary
- Support Quality Management Team (QMT) by providing monthly/quarterly updates based on role and responsibilities
- Support process improvement of QA department, KPI/QPI tracking and oversight.
- Manage GCP/GVP/GLP consultant(s) as needed
QUALIFICATIONS
Education /Experience:
- Bachelor’s Degree in a scientific discipline.
- 10-12 years of experience in the pharmaceutical industry, including 5-10 years in GCP Quality and 5+ years supervising GCP Quality internal staff and/or external consultants.
- Knowledge and demonstrated experience in the applicable GCP regulations, FDA Regulations and Good Clinical Practices, EMA EudraLex Regulations, and ICH Guidelines.
- Strong verbal and written communication.
- Knowledge of basic GVP, GCLP and GLP regulations.
The salary range for this position is $190,000 to $205,000 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.
Skills Required
- Bachelor's Degree in a scientific discipline
- 10-12 years of experience in the pharmaceutical industry
- 5-10 years in GCP Quality
- 5+ years supervising GCP Quality staff or consultants
- Knowledge of GCP regulations, FDA Regulations, and ICH Guidelines
Mirum Pharmaceuticals Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Mirum Pharmaceuticals and has not been reviewed or approved by Mirum Pharmaceuticals.
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Equity Value & Accessibility — Equity grants to new hires and an employee stock purchase plan make ownership more accessible and can boost total rewards when performance is strong. Public disclosures highlight frequent option/RSU inducements.
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Healthcare Strength — Comprehensive medical, dental, and vision coverage is employer-paid for employees, with added life, disability, and EAP support. This combination reduces financial burden and enhances overall wellbeing.
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Leave & Time Off Breadth — A broad time-off program includes multiple paid company holidays, a year-end shutdown, accrued vacation, and paid parental leave. This breadth provides additional rest periods beyond standard vacation.
Mirum Pharmaceuticals Insights
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.
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