---
title: 'Associate Director, Quality System, QMS at Mirum Pharmaceuticals'
canonical: 'https://feeny.ai/job/associate-director-quality-system-qms-mirum-pharmaceuticals-foster-city-1tt1tp333ejw'
type: 'job'
last_seen: '2026-09-09'
---

# Associate Director, Quality System, QMS at Mirum Pharmaceuticals

- **Company:** Mirum Pharmaceuticals
- **Location:** Foster City, CA
- **Posted:** 2026-04-27
- **Last confirmed live:** 2026-09-09
- **Apply:** https://job-boards.greenhouse.io/mirumpharmaceuticals/jobs/5119672007

## Job description

## 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 $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.

## #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.

## About Mirum Pharmaceuticals

## Company Overview
- **One-liner**: Mirum Pharmaceuticals is a global biopharmaceutical company focused on developing and delivering treatments for rare liver diseases affecting children and adults with significant unmet medical needs.
- **Entity Type**: Public (NASDAQ: MIRM)
- **Headquarters**: Foster City, California, USA
- **Founded**: 2018
- **Founders**: Not publicly listed as individual founders; the company was established by a leadership team with deep rare disease and biotech experience who identified a deprioritized therapy for Alagille syndrome and moved decisively to advance it.

## Core Business
- **Primary industry/industries**: Biotechnology / Rare Disease Pharmaceuticals
- **Target customers**: Healthcare providers, patients, and families affected by rare liver diseases (Alagille syndrome, Progressive Familial Intrahepatic Cholestasis, and other cholestatic conditions); B2B relationships with payers, distributors, and healthcare systems globally.
- **Mission or purpose statement**: "Relentlessly Rare" — focused on conditions where the burden is profound and the need is greatest, combining deep expertise with disciplined execution to advance meaningful medicines for people around the world.

## Products & Services
- **LIVMARLI® (maralixibat)**: An oral, once-daily ileal bile acid transporter (IBAT) inhibitor approved for the treatment of cholestatic pruritus in Alagille syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC). Approved in multiple regions including the US and Europe. Additional development programs are underway.
- **Pipeline Programs**: A broad pipeline of investigational medicines targeting significant unmet needs in rare liver diseases, including additional indications for LIVMARLI and other early-stage programs.

## Market Standing
- **Valuation/Market Cap**: As of mid-2025, Mirum’s market capitalization is approximately $1.5–$2.0 billion (fluctuating with stock price; check current data on [ir.mirumpharma.com](https://ir.mirumpharma.com/overview/default.aspx)).
- **Key Metric**: Annual Revenue — Mirum generates revenue from commercial sales of LIVMARLI. In 2024, the company reported total revenue of approximately $290 million (preliminary figure; verify in latest 10-K). The company has transitioned from a development-stage to a commercial-stage biotech.
- **Notable Investors/Partners**: Public institutional investors; key partners include clinical sites, patient advocacy groups (e.g., Alagille Syndrome Alliance, PFIC Network), and global distribution partners for international markets.
- **Growth Signals**: Three approved medicines in its portfolio; global footprint with offices in North America and Europe; expanding pipeline with additional clinical programs; consistent revenue growth from LIVMARLI; growing commercial presence in Europe and other regions.

## Competitive Advantages
- **First-in-class / Best-in-class therapy**: LIVMARLI is the first and only approved treatment for cholestatic pruritus in Alagille syndrome, addressing a critical unmet need with no prior approved therapies.
- **Deep rare disease expertise**: The leadership team has extensive experience in rare disease drug development, regulatory strategy, and commercialization, allowing the company to navigate complex pathways efficiently.
- **Patient-centric culture**: Mirum embeds patient and family voices directly into development and commercial strategy, ensuring therapies meet real-world needs.
- **Disciplined execution**: The company was founded with a single deprioritized asset and rapidly advanced it to approval, demonstrating agility and focus.

## Strategic Focus
- **Expand global access**: Continuing to secure regulatory approvals and market access for LIVMARLI and other pipeline assets across North America, Europe, and other regions.
- **Advance pipeline**: Pursuing additional indications for LIVMARLI and developing new therapies for other rare liver diseases with high unmet need.
- **Deepen patient engagement**: Strengthening relationships with patient communities and advocacy groups to inform research, development, and commercialization.
- **Build commercial infrastructure**: Expanding commercial, medical affairs, and patient services teams globally to support growing product portfolio.

## Why Work Here
- **Mission-driven culture**: Mirum’s core values — "Care, Be Real, Get It Done, and Have Fun, Seriously" — foster a collaborative, high-performance environment where employees are empowered to bring their authentic selves to work.
- **Flexible work environment**: The company supports flexible ways of working, with offices in Foster City (global HQ), Basel (Switzerland), and Zug (Switzerland), plus US Remote roles available for certain positions. Arrangements vary by role.
- **Comprehensive benefits**: 100% employee medical premium coverage (with 100% dependent medical contributions), 4% 401(k) match with immediate vesting, 15% Employee Stock Purchase Plan, four weeks of PTO starting day one, company holidays including a winter shutdown, paid parental leave, up to $5,000 annual tuition reimbursement, and an Employee Assistance Program.
- **Collaborative community**: Regular "Coffee and Chats" and bi-weekly "Lunch Connections" foster cross-functional dialogue. Office environments are designed for connection with stocked snacks, beverages, and (in some locations) catered lunches and on-site baristas.
- **Growth opportunity**: As a high-growth public company with approved products and an expanding pipeline, employees have significant opportunities to contribute to meaningful milestones and career development.

## Sources
1. [mirumpharma.com](https://mirumpharma.com/)
2. [mirumpharma.com/about-us/our-story/](https://mirumpharma.com/about-us/our-story/)
3. [mirumpharma.com/jobs/](https://mirumpharma.com/jobs/)
4. [ir.mirumpharma.com](https://ir.mirumpharma.com/overview/default.aspx)
5. [job-boards.greenhouse.io/mirumpharmaceuticals](https://job-boards.greenhouse.io/mirumpharmaceuticals)

## Other roles at Mirum Pharmaceuticals

- [Senior Manager, IT - Field Engagement Platforms](https://feeny.ai/job/senior-manager-it-field-engagement-platforms-mirum-pharmaceuticals-foster-city-y7cke5ym86d9) — Foster City, CA
- [Associate Director, IT – Commercial Data & Insights Architect](https://feeny.ai/job/associate-director-it-commercial-data-insights-architect-mirum-pharmaceuticals-g9wsr1x11bam) — Foster City, CA
- [Senior Manager, Regulatory Affairs Labeling](https://feeny.ai/job/senior-manager-regulatory-affairs-labeling-mirum-pharmaceuticals-foster-city-cd12qjwbgvy7) — Foster City, CA
- [Associate Director, Marketing - Brelovitug](https://feeny.ai/job/associate-director-marketing-brelovitug-mirum-pharmaceuticals-foster-city-4shheq22p8dm) — Foster City, CA
- [Therapeutic Account Manager, Liver - Manhattan North](https://feeny.ai/job/therapeutic-account-manager-liver-manhattan-north-mirum-pharmaceuticals-united-kvtpdmvp9w2m) — United States
- [Therapeutic Account Manager, Liver - Miami](https://feeny.ai/job/therapeutic-account-manager-liver-miami-mirum-pharmaceuticals-united-states-s54276gcfgz2) — United States
- [Therapeutic Account Manager, Liver - Jacksonville](https://feeny.ai/job/therapeutic-account-manager-liver-jacksonville-mirum-pharmaceuticals-united-5b19z5vw3cc1) — United States
- [Therapeutic Account Manager, Liver - Charlotte](https://feeny.ai/job/therapeutic-account-manager-liver-charlotte-mirum-pharmaceuticals-united-states-j3bvmf57a95r) — United States
- [Therapeutic Account Manager, Liver - Richmond](https://feeny.ai/job/therapeutic-account-manager-liver-richmond-mirum-pharmaceuticals-united-states-jabdwhfcyq8s) — United States
- [Therapeutic Account Manager, Liver - Washington, D.C.](https://feeny.ai/job/therapeutic-account-manager-liver-washington-d-c-mirum-pharmaceuticals-united-aq4qrnkceqbr) — United States