Associate Director, GCP QA
Mirum Pharmaceuticals, Inc.
4 hours ago
Remote friendly (Foster City, CA)
United States
$190,000 - $205,000 USD yearly
Clinical Research and Development
Position Summary
- The Associate Director of GCP/GVP/GLP-QA supports Mirum’s clinical study programs as the GCP-QA representative on the study management team.
- Manages GCP quality assurance activities and compliance with applicable regulatory requirements.
- Develops and implements policies/procedures to ensure quality standards in line with relevant regulatory and quality guidelines.
- Supports GVP and GLP QA operational activities to ensure data integrity and meet regulatory expectations and industry standards.
Job Functions/Responsibilities
- Achieve established timelines for deliverables.
- Serve as QA Representative for assigned clinical study management teams.
- Manage/Support BIMO inspection readiness activities.
- Support GCP/GCLP/GVP internal audits.
- Provide quality oversight for GCP/GVP/GLP vendor activities, including deviations, CAPAs, change controls, and KPIs/KQIs.
- Support GCP/GCLP/GVP vendor management/audit program (ad hoc audits as requested).
- Support clinical site management/audit program (ad hoc site audits as requested).
- Assist with and support regulatory agency inspections for GCP and PV impacted functions.
- Provide GCP/GCLP/GVP training as necessary.
- Provide monthly/quarterly updates to Quality Management Team (QMT) based on role/responsibilities.
- Support QA process improvement, including KPI/QPI tracking and oversight.
- Manage GCP/GVP/GLP consultants as needed.
Qualifications
- Bachelor’s degree in a scientific discipline.
- 10–12 years in the pharmaceutical industry, including 5–10 years in GCP Quality and 5+ years supervising GCP Quality internal staff and/or external consultants.
- Demonstrated knowledge of 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 Associate Director of GCP/GVP/GLP-QA supports Mirum’s clinical study programs as the GCP-QA representative on the study management team.
- Manages GCP quality assurance activities and compliance with applicable regulatory requirements.
- Develops and implements policies/procedures to ensure quality standards in line with relevant regulatory and quality guidelines.
- Supports GVP and GLP QA operational activities to ensure data integrity and meet regulatory expectations and industry standards.
Job Functions/Responsibilities
- Achieve established timelines for deliverables.
- Serve as QA Representative for assigned clinical study management teams.
- Manage/Support BIMO inspection readiness activities.
- Support GCP/GCLP/GVP internal audits.
- Provide quality oversight for GCP/GVP/GLP vendor activities, including deviations, CAPAs, change controls, and KPIs/KQIs.
- Support GCP/GCLP/GVP vendor management/audit program (ad hoc audits as requested).
- Support clinical site management/audit program (ad hoc site audits as requested).
- Assist with and support regulatory agency inspections for GCP and PV impacted functions.
- Provide GCP/GCLP/GVP training as necessary.
- Provide monthly/quarterly updates to Quality Management Team (QMT) based on role/responsibilities.
- Support QA process improvement, including KPI/QPI tracking and oversight.
- Manage GCP/GVP/GLP consultants as needed.
Qualifications
- Bachelor’s degree in a scientific discipline.
- 10–12 years in the pharmaceutical industry, including 5–10 years in GCP Quality and 5+ years supervising GCP Quality internal staff and/or external consultants.
- Demonstrated knowledge of 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.