New · posted Oct 15
Mirum Pharmaceuticals · Pharmaceuticals
Director, GMP Quality Assurance
- Foster City, CA
- Hybrid
- Full-time
- Director
Open until filled
The role
The Director, GMP Quality Assurance 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 also 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 Associate Director/Director is accountable for the quality and timely delivery of activities within the role’s scope.
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.
What you need
Education /Experience
- Bachelor’s degree in a scientific discipline required; advanced degree (MS or PhD) preferred.
- 10+ years of experience in the pharmaceutical or biotechnology industry, including 8+ 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.
- 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.
- Prior hands-on or leadership experience within a GMP Quality Control (QC) laboratory environment is highly desirable
- Excellent communication, collaboration, leadership, problem-solving, and risk management skills.
Pay
$220,000 – $240,000 a year
Employer providedThe salary range for this position is $220,000 to $240,000 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.
Where you'll work
Foster City, CAHybridOpen in Maps (opens in a new tab)
More jobs in Foster City, CAWorking conditions
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.
Equal opportunity, accessibility and legal noticesMirum Pharmaceuticals's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 10% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Director roles in California26 roles publishing pay
Director roles in the US102 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $220,000 | — | $240,000 |
| California (middle half) | $197,500 | $213,500 | $241,000 |
| All US (middle half) | $186,500 | $209,250 | $231,375 |
This role: Mirum Pharmaceuticals's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Mirum Pharmaceuticals's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 17 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance8
- Collaboration and leadership4
- Lab testing and methods2
- Regulatory submissions2
- Quality systems and risk2
- Validation and qualification1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDAFDA process validation guidance(official source, opens in a new tab)Process Validation: General Principles and Practices
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- European CommissionEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules and annexes
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
- FDAFDA NDA(official source, opens in a new tab)New Drug Applications
Company hiring pulse
Mirum Pharmaceuticals on Regulatory Jobs
- 7
- Open roles
- 7
- Distinct roles
- 1
- Locations
By discipline
- Regulatory5 71%
- Quality2 29%
By level
- Director5 71%
- VP & Executive1 14%
- Manager1 14%
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Director, GMP Quality Assurance at Mirum Pharmaceuticals
Open until filled. $220K–$240K a year, employer provided.