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
We are seeking an experienced Director, GMP Quality Assurance (QA) Operations to provide strategic and operational leadership in managing quality for outsourced manufacturing and testing operations, ensuring product quality, regulatory compliance, and reliable supply of clinical material. This role will be a key cross-functional partner, and will work closely with CMC, Supply Chain, Quality Control, and Regulatory teams to drive quality strategy, continuous improvement, and operational excellence. It would be specializing in QA support of late phase development to commercial biologics manufacturing.
Responsibilities:
- Manage and provide oversight of routine operations conducted by external partners, including CDMOs and testing labs
- Provide timely feedback for GMP quality events and escalate to management for aligned decisions, as appropriate.
- Ensure timely batch record review, product disposition, and compliance with regulatory requirements
- Develop and monitor partner performance metrics, risk assessments, and escalation pathways
- Collaborate with internal CMC, Regulatory, Quality Control, and Supply Chain teams to support technical transfers, process development, and regulatory submissions
- Serve as GMP SME for cross-functional initiatives to strengthen quality systems, enhance compliance, and drive operational efficiency
- Serve as a primary QA representative during regulatory inspections (FDA, EMA, and other global authorities), including hosting inspections, responding to questions, and managing commitments.
- Own inspection follow-up activities, including CAPA development, execution, and effectiveness verification.
- Champion a culture of quality and inspection readiness across internal and external operations
Qualifications:
- Bachelor’s or advanced degree in Biology, Chemistry, Chemical Engineering, or related scientific field
- 10+ years of progressive cGMP Quality Assurance experience supporting biologics manufacturing and analytical testing in a regulated environment, Person in Plant, and direct Inspection experience with domestic and international regulatory agencies
- Direct experience managing external partners/CDMOs and ensuring compliance from clinical supply through validation to commercial supply
- Strong knowledge of FDA, EMA, ROW CGMP regulations, and ICH guidance
- This is a hybrid on-site / remote work schedule, with 3 days on-site per week
The salary range for this position is $220,000 to $235,000 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.
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.
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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.
