Associate Director, GCP QA

mirumpharmaceuticals· Quality Assurance
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📍 Foster City

About this role

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 Associate Director of GCP/GVP/GLP-QA is responsible for supporting Mirum’s clinical study programs as the GCP-QA representative on the study management team; managing activities involving GCP quality assurance and compliance with applicable regulatory requirements; development and implementation of policies and procedures to ensure quality standards in compliance with relevant regulatory and quality guidelines. Additionally, this position will support GVP and GLP QA operational activities to ensure data integrity and meeting regulatory expectations and industry standards. 

This position requires experience with global contract research organizations (CROs) and GCP Vendors as well as knowledge of global GCP regulations.

JOB FUNCTIONS/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

QUALIFICATIONS

Education /Experience:

  • 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.

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.

 

Frequently Asked Questions

Is the salary disclosed for the Associate Director, GCP QA position at mirumpharmaceuticals?
The salary for this Associate Director, GCP QA role at mirumpharmaceuticals is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Associate Director, GCP QA position at mirumpharmaceuticals located?
This Associate Director, GCP QA role at mirumpharmaceuticals is based in Foster City. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Which team or department does the Associate Director, GCP QA at mirumpharmaceuticals belong to?
This Associate Director, GCP QA position is part of the Quality Assurance department at mirumpharmaceuticals. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Associate Director, GCP QA position at mirumpharmaceuticals?
Click the "Apply Now" button on this page. You will be redirected to mirumpharmaceuticals's official application portal hosted on greenhouse where you can submit your application directly.
When was the Associate Director, GCP QA job at mirumpharmaceuticals posted?
This Associate Director, GCP QA position at mirumpharmaceuticals was posted on Feb 3, 2026. Apply as soon as possible — early applications are often reviewed first.
Associate Director, GCP QA
mirumpharmaceuticals
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