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
Leads roll out and oversight of Veeva QMS modules, ensuring compliance with applicable regulatory requirements. Manages the development, implementation, and continuous improvement of policies and procedures to maintain quality standards aligned with global regulatory and company guidelines. Partners cross-functionally to ensure effective execution of quality processes. Applies strong knowledge of global regulations to support compliant and efficient operations. Contributes to the strategic direction and ongoing performance of the Quality Management System (QMS), driving consistency, inspection readiness, and continuous improvement initiatives.
JOB FUNCTIONS/RESPONSIBILITIES
- Lead the end-to-end implementation and rollout of new modules within Veeva, ensuring alignment with business needs and regulatory requirements.
- Serve as the Quality Systems lead and subject matter expert (SME) processes, driving standardization and harmonization across the organization.
- Partner with cross-functional stakeholders (Quality Assurance, Manufacturing, Supply Chain, and IT) to define system requirements, workflows, and business processes.
- Oversee system configuration, user acceptance testing (UAT), and validation activities (e.g., CSV/CSA) to ensure the system is fit for intended use and compliant with global GMP regulations.
- Assist with developing and executing implementation plans, including timelines, resource planning, risk mitigation strategies, and communication plans.
- Author and/or review governing documents (SOPs, work instructions, and training materials) to support the new modules and ensure alignment with QMS requirements.
- Lead training strategy and rollout, including role-based curricula, to ensure successful user adoption and adherence to new processes.
- Monitor system performance and user feedback post-implementation; identify and implement continuous improvements and enhancements.
- Collaborate with internal stakeholders to ensure alignment and effective utilization of newly implemented and current modules.
- Act as the primary point of contact for system-related issues, deviations, and change controls.
- Support internal and external audits and health authority inspections by providing system documentation, demonstrating functionality, and addressing inquiries.
QUALIFICATIONS
Education /Experience:
- Bachelor’s degree in scientific discipline
Knowledge, Skills and Abilities:
- 12+ years’ experience and strong background in Quality and Quality Systems in the drug development industry with knowledge of cGMP/ICH/FDA/EMA regulations
- Prior experience implementing or supporting electronic QMS platforms, ideally Veeva Vault QMS
- Strong project management and change management skills is a plus
- Ability to drive process standardization and continuous improvement
- Demonstrate a quality mindset and ability to influence across the organization
- Successful experience writing and reviewing SOPs and other Quality documents.
- Expert knowledge of phase appropriate cGxPs and experience leading Quality System implementation and continuous improvement efforts.
- Demonstrated ability to successfully interact with regulatory health authorities at inspections and thorough understanding of audit and vendor management programs.
- Excellent organizational skills: Proactive, management of multiple tasks of varying complexity simultaneously
- Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment.
The salary range for this position is $197,129 to $221,404 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.
#LI-HYBRID
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 scientific discipline
- 12+ years' experience in Quality and Quality Systems in drug development
- Prior experience implementing or supporting electronic QMS platforms
- Strong project management and change management skills
- Expert knowledge of phase appropriate cGxPs
- Excellent organizational skills managing multiple tasks
- Strong interpersonal skills including relationship building
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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