Quality Management Lead
1 day ago
The Senior Manager, Global Quality Management will be responsible for managing and performing audits with a focus on Computer System Validation (CSV) audits. Key responsibilities include:
• Supporting the development, implementation, and continuous improvement of the company's quality system
• Managing inspections, audits, regulatory intelligence activities, SOP and WP management, and project liaison activities
• Collaborating with the Head of Global Quality Management, Senior Director Global Quality Management, and the CSV Audit Lead to ensure the success of the global quality management team
• Ensuring compliance with relevant regulations and guidance documents
• Providing advice and acting as a project liaison as needed
Requirements:
To be successful in this role, you will need a degree in natural science or equivalent business experience and several years of experience in the IT industry, pharmaceutical industry, or relevant regulatory authority experience. Expert knowledge of relevant regulations and guidance documents, experience as a lead auditor on internal audits and external vendor audits, GxP related CSV audits and inspections, and knowledge and understanding of computerised systems in the GxP environment are highly desirable. Understanding of computer hardware and network/infrastructure requirements is also necessary.
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