Manager, Global Quality Systems
BioNTech SE
full-time
Posted on:
Location Type: Office
Location: Mainz • Germany
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About the role
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Quality Management Systems (QMS)electronic QMS (eQMS)Veeva Quality SuiteGxP regulationspharmaceutical quality systemsend-to-end QMS processesdocument controlchange controlsdeviationsquality projects
Soft Skills
analytical skillsproblem-solving skillsproactive capabilitiesmotivation to work in an agile environmentcontinuous improvement mindsetorganizational alignmentadvocacy for harmonized ways of working