Director of Global Quality Management Systems
2 settimane fa
About the Role: We are seeking an exceptional professional to lead our Pharmacovigilance and Quality Management Systems team as an Associate Director. The ideal candidate will have a strong background in Pharmacovigilance/Drug Safety, Regulatory Affairs, or Quality Assurance within the pharmaceutical/biotech industry.
Responsibilities:
- Develop and maintain the Pharmacovigilance Quality Management System in collaboration with subject matter authorities.
- Coordinate the assignment of adverse event and product complaint training globally to vendors.
- Create a comprehensive training program for all individuals within the GPS and relevant personnel involved in GVP.
- Regularly review all procedures to ensure they accurately reflect the GPS activities being followed.
- Monitor compliance with required training and address non-compliance by working with line management.
- Lead initiatives to continuously improve the effectiveness and efficiency of GPS processes.
- Maintain the AE-PC contract language and liaise with Legal, Procurement, and Commercial as needed to support contract review/update.
Requirements:
- A minimum of 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.
- A consistent record of successful project management related to quality management.
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