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Associate Director, QA Audits
Job Summary
A company is looking for an Associate Director, QA Audits & Inspections Program.
Key Responsibilities
- Champion and adhere to the Quality Management System (QMS) and assist in crafting QA organizational goals
- Mentor a team of Quality professionals, ensuring compliance with regulations and timely quality deliverables
- Oversee internal and external QA audits, manage Sponsor audits, and participate in regulatory inspections
Required Qualifications
- Bachelor's degree in nursing, biological, physical, health, pharmacy, or related science
- 8+ years of relevant GCP experience or equivalent work experience
- Experience in conducting various types of QA audits, including Clinical Investigator and Vendor Audits
- Previous participation in regulatory inspections (e.g., FDA, MHRA, Health Canada)
- Broad understanding of quality and regulatory compliance related to GxP activities, specifically GCP knowledge
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COMPLETE JOB DESCRIPTION
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Company Overview
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