Associate Director, GCP QA

Role Summary

The Associate Director of GCP QA will lead GCP/GVP/GLP QA activities for Mirum's clinical study programs as the GCP-QA representative on the study management team. They will manage activities involving GCP quality assurance and regulatory compliance, and develop and implement policies and procedures to ensure quality standards. They will also support GVP and GLP QA operational activities to ensure data integrity and regulatory alignment. This role requires experience with global CROs and GCP Vendors and knowledge of global GCP 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 oversight 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

• 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.

Education

• Bachelor's Degree in a scientific discipline.