Associate Director, GCP QA
About The Position
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.
Requirements
- 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.
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
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What This Job Offers
Job Type
Full-time
Career Level
Director
