Mirum Pharmaceuticals, Inc. · 2 hours ago
Associate Director, GCP QA
Foster City
Full-time
Hybrid
Lead/Staff, Director/Executive
$190K/yr - $205K/yr
10+ years expMirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. The Associate Director of GCP/GVP/GLP-QA is responsible for managing GCP quality assurance and compliance for clinical study programs, ensuring adherence to regulatory requirements and quality standards.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
Achieve established timelines for deliverables
QA Representative for assigned Mirum’s Program’s Clinical Study Management Teams
Manage/Support BIMO inspection readiness activities
Support GCP/GCLP/GVP internal audits
Provide quality oversite for the GCP/GVP/GLP vendor activities, including internal/external deviations, CAPAs, change controls, and KPIs/KQIs
Support GCP, GCLP and GVP Vendor Management/Audit Program. Ad hoc audits may be requested
Assist with planning and supporting Clinical Site Management/Audit Program. Ad hoc site audits may be requested
Assist with and support regulatory agency inspections for the GCP and PV impacted functions
Provide GCP/GCLP/GVP Training as necessary
Support Quality Management Team (QMT) by providing monthly/quarterly updates based on role and responsibilities
Support process improvement of QA department, KPI/QPI tracking and oversight
Manage GCP/GVP/GLP consultant(s) as needed
Qualification
Required
Bachelor's Degree in a scientific discipline
10-12 years of experience in the pharmaceutical industry, including 5-10 years in GCP Quality and 5+ years supervising GCP Quality internal staff and/or external consultants
Knowledge and demonstrated experience in the applicable GCP regulations, FDA Regulations and Good Clinical Practices, EMA EudraLex Regulations, and ICH Guidelines
Strong verbal and written communication
Knowledge of basic GVP, GCLP and GLP regulations
Benefits
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.
Company
Mirum Pharmaceuticals, Inc.
Mirum Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults.
201-500 employees
H1B Sponsorship
Mirum Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (2)
2023 (1)
2022 (1)
2021 (1)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$765.5MKey Investors
TCG CrossoverOberland CapitalNew Enterprise Associates
2025-12-19Post Ipo Equity· $68.5M
2025-12-08Post Ipo Equity· $200M
2023-04-12Post Ipo Equity· $275M
Leadership Team
Joanne Quan
Chief Medical Officer
Recent News
The Motley Fool
2026-01-14
2026-01-13
Company data provided by crunchbase