Associate Director, GCP QA

Benefits

Parental leave

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Non-birth-parent leave

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Family-building benefits

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• Adoption assistance: Not verified
• Surrogacy assistance: Not verified

Mental health support

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Relocation assistance

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Childcare support

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Learning budget

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Verification

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Salary

$190K-$205K not verified - source not recorded; timestamp not recorded

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Schedule

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Weekend work

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Application

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Assessment

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Deadline

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Where they hire

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About this role

Associate Director, GCP QA Foster City 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

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