---
title: 'Senior Director, GMP Quality Assurance at Mirum Pharmaceuticals'
canonical: 'https://feeny.ai/job/senior-director-gmp-quality-assurance-mirum-pharmaceuticals-foster-city-6zyxc9chs0ar'
type: 'job'
last_seen: '2026-11-04'
---

# Senior Director, GMP Quality Assurance at Mirum Pharmaceuticals

- **Company:** Mirum Pharmaceuticals
- **Location:** Foster City, CA
- **Posted:** 2026-04-14
- **Last confirmed live:** 2026-11-04
- **Apply:** https://job-boards.greenhouse.io/mirumpharmaceuticals/jobs/5108395007

## 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

The Senior Director, GMP Quality is responsible for the global oversight and management of GMP Quality Assurance operations supporting development and commercial programs. The role manages multiple complex priorities, provides technical and compliance leadership, resolves quality issues, and collaborates cross-functionally with internal stakeholders and external partners to support product quality, regulatory compliance, and continuity of clinical and commercial supply.

The position primarily provides oversight of clinical and commercial Good Distribution Practice (GDP) activities, including compliance with applicable U.S., EU/UK, and other global GDP requirements including the U.S. DSCSA, serialization, track-and-trace, and exception management requirements. The Senior Director is accountable for the quality and timely delivery of activities within the role’s scope.

## JOB FUNCTIONS/RESPONSIBILITIES

- Provide QA oversight of finished product (FP), from early development through commercialization.
- Provide QA oversight of clinical and commercial product distribution activities in accordance with applicable GDP requirements, DSCSA, serialization, track-and-trace, and exception management requirements as appropriate.
- Support the development and approval of commercial labeling, including prepress activities, proofreading of labeling artwork, and anti-counterfeiting activities.
- Perform lot disposition activities, including batch record review; review of in-process, release, and stability testing; and assessment of quality events associated with GMP products and processes.
- Provide QA oversight across the product development lifecycle, including drug substance (DS) and drug product (DP) from early development through commercialization.
- Review and approve protocols and reports related to technology transfer, process validation, method transfer, method qualification and validation, and expiry dating, as applicable.
- Lead quality-related discussions, investigations, risk assessments, and change controls to ensure potential product quality issues are appropriately evaluated, addressed, documented, and justified.
- Provide technical expertise and guidance for internal and external deviations, laboratory investigations, change controls, and related quality events; ensure appropriate tracking, follow-up, and timely resolution in collaboration with responsible functions and external partners.
- Author, review, and negotiate Quality Agreements with GxP vendors, intra-company sites, alliance partners, and investigator-sponsored trial (IST) partners, as applicable.
- Author, coordinate the preparation, review, approval, and timely completion of Annual Product Reviews/Product Quality Reviews (APR/PQRs), as applicable.
- Perform compliance gap assessments, identify appropriate remediation actions, and drive implementation to completion.
- Communicate manufacturing deficiencies and nonconformances to management and work with external partners to ensure timely and effective resolution.
- Review and support regulatory and quality documentation for submissions, including INDs, CTAs, IMPDs, NDAs, and MAAs, as applicable.
- Interface with regulatory authorities, host third-party GMP audits, and support CMO pre-approval inspections (PAIs) and other regulatory inspections, as needed.
- Champion continuous improvement by identifying, leading, and monitoring initiatives that enhance quality, compliance, and operational effectiveness.
- Be willing and able to travel up to 20%, including international travel.
- Perform other duties as assigned.

## QUALIFICATIONS

Education /Experience:

- Bachelor’s degree in a scientific discipline required; advanced degree (MS or PhD) preferred.
- 15+ years of experience in the pharmaceutical or biotechnology industry, including 12+ years of experience in GMP Quality Assurance. Experience in clinical and/or commercial labeling and last-mile commercial operations is required.
- Strong knowledge of and demonstrated experience with applicable global GMP and GDP requirements, including FDA regulations, EU GMP (EudraLex Volume 4), ICH guidelines, and distribution requirements for clinical and commercial products.
- Demonstrated experience supporting product development from early-stage development through global commercialization.
- Strong knowledge of CMC development, process validation, technology transfer, and small-molecule manufacturing operations.
- Strong knowledge of method development, method validation, and method transfer
- Hands on QC experience a plus.
- Experience supporting regulatory submissions (e.g., IND, CTA, IMPD, NDA, MAA) and health authority inspections, including PAIs.
- Experience overseeing international CMOs, contract testing laboratories (CTLs), contract packaging organizations (CPOs), third-party logistics providers (3PLs), and distributors.
- Experience with global serialization, track-and-trace, and DSCSA exception management is preferred.
- Strong understanding of the global pharmaceutical supply chain and product lifecycle management.
- Demonstrated experience with inspection readiness and continuous improvement of quality and compliance processes.
- Excellent communication, collaboration, leadership, problem-solving, and risk management skills.

The salary range for this position is $280,000 to $300,000 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)

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