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Sr Director of QMS And Auditing
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- The Sr Director of Quality Management and Auditing will be responsible for overseeing the development, implementation, and maintenance of the Quality Management System (QMS) to ensure compliance with FDA (Food and Drug Administration), CBER (Center for Biologics Evaluation and Research), and CDER (Center for Drug Evaluation and Research) regulations and guidelines.
- Develop and implement strategies to establish and maintain a comprehensive Quality Management System (QMS) that meets FDA, CBER, and CDER requirements.
- Conduct regular audits and assessments of the QMS to identify areas for improvement and ensure ongoing compliance with FDA, CBER, and CDER regulations.
- Stay abreast of changes in FDA, CBER, and CDER regulations and guidelines and ensure that the QMS is updated accordingly.
- Provide guidance and support to departments across the organization on quality-related matters, including document control, training, and CAPA (Corrective and Preventive Action) processes.
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