Manager for Global Quality Systems at BioNTech supporting the implementation of Quality Management Systems (QMS). Ensuring organizational alignment and driving improvements using the Veeva Quality Suite.
Responsibilities
support the implementation and development of BioNTech’s Quality Management System (QMS) and electronic QMS (eQMS) using the Veeva Quality Suite within the OneQMS framework
ensure full organizational alignment and support operational activities within Global Quality Systems
develop QMS frameworks and drive improvements in QMS and eQMS systems
design and implement end-to-end QMS processes for efficient execution and scalability
ensure alignment with regulatory expectations and internal quality standards
support standard operational global QA activities as required, including Quality Projects, Change Controls, Deviations, Document Control, and Migrations
promote a strong OneQMS mindset across teams and functions, advocating for continuous improvement and harmonized ways of working
Requirements
degree in pharmacy, chemistry, biology, or a related scientific field
at least 3 years of experience in Quality Assurance, with a focus on Quality Management Systems (QMS) and electronic QMS (eQMS) implementation
solid understanding of GxP regulations and pharmaceutical quality systems, with experience in both global and local project environments
hands-on experience in designing and implementing end-to-end QMS processes, ensuring alignment with regulatory expectations and internal quality standards
strong analytical and proactive capabilities, as well as problem-solving skills to effectively drive quality improvements and harmonized ways of working
motivated to work in an agile environment, embracing change and continuous improvement
fluent in English, proficiency in German is considered a plus.
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