Quality Assurance Manager
7 days ago
We are seeking an experienced professional to join our team as an Associate Director, Gps Standards & Training at Regeneron Ireland DAC. The ideal candidate must have at least 7+ years of experience in Pharmacovigilance/Drug Safety, Regulatory Affairs, or Quality Assurance within the pharmaceutical/biotech industry, a Bachelor's degree is required, previous extensive knowledge and experience within Pharmacovigilance/Drug Safety regulations and PV Quality Management Systems, and a consistent record of successful project management related to quality management.
In this role, you will be responsible for developing and maintaining the PV Quality Management System in collaboration with subject matter authorities, coordinating the assignment of adverse event (AE) & product complaint (PC) training globally to vendors, creating a comprehensive training program for all individuals within the GPS and relevant personnel involved in GVP, regularly reviewing procedures to ensure they accurately reflect the GPS activities being followed, monitoring compliance with required training and addressing non-compliance by working with line management, and leading or participating in initiatives to continuously improve the effectiveness and efficiency of GPS processes.
Key Skills and Qualifications:
- At least 7+ years of experience in Pharmacovigilance/Drug Safety, Regulatory Affairs, or Quality Assurance within the pharmaceutical/biotech industry.
- Bachelor's degree is required.
- Previous extensive knowledge and experience within Pharmacovigilance/Drug Safety regulations and PV Quality Management Systems.
- A consistent record of successful project management related to quality management.
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