QA Expert*

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QA Expert*
As a QA Expert*, you support the implementation of clinical or commercial manufacturing processes at the Marburg site within technology transfers, process development or investment projects, ensuring that regulatory, internal and GxP requirements are met. With your expertise, you are the contact person* in the Quality Operations department and provide the interface to the production areas and operational departments.
Your main responsibilitiesa are:

• Expert for the operational application of existing quality systems in the implementation of new manufacturing processes for precursors, drug substance or drug product and the associated analytics and release procedures
• Interdisciplinary exchange with project participants within investment and improvement projects and classification/transfer of quality-relevant issues into the quality organisation as well as development of appropriate solution approaches
• Initiation and coordination of process improvements and best practices to harmonise procedures for different projects
• Participation in the further development of an agile quality organisation by applying existing risk management and applying the current GxP regulations
• Establishment of concepts for compliance of new manufacturing and release processes of the respective products with the respective valid GxP requirements
• Carrying out Quality on the Shop-Floor (QASF) activities in compliance with site procedures
• Provision and transfer of expertise in the area of Quality Operations and the adjacent departments
• Preparation, revision and review of sectoral documents, plans and reports
• Management of derogations, amendments, corrective and preventive measures
• QA contact person* in the context of official inspections, e.g. for obtaining the manufacturing licence
  

What you have to offer:

• Graduate in science or engineering or equivalent with several years' experience in pharmaceutical manufacturing
• Several years of industry experience in a GxP-regulated environment
• Sound experience in supporting projects in the pharmaceutical environment and/or sound experience in the QA-side supervision of technology transfers or process developments
• Sound, demonstrable knowledge of the GxP rules and regulations, especially in the implementation of clinical and commercial manufacturing processes
• Excellent team and communication skills
• Analytical, risk-based and conceptual thinking and action
• High level of understanding of quality, personal responsibility and conscientiousness
• German & English fluent in written and spoken
• Excellent computer skills, especially Microsoft Office, databases, SAP
  

We offer:

• A modern and employee-oriented corporate and management culture
• Team spirit and a work environment in which you will feel comfortable
• Exciting opportunities for further development
• Employment with remuneration according to the collective agreement for the chemical industry in Hesse
• Possibility of remote working
• Company bike
• Subsidy for job ticket
• Company pension plan
• Supplementary nursing care insurance according to collective agreement
• and much more.
  

Have we kindled your pioneering spirit?
Then apply now for our Marburg location and simply send us your application documents using our online form.
If you have any further questions, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon to 4 pm).
Job-ID 6482 (please indicate for inquiries)
We look forward to your application!

• BioNTech does not differentiate on the basis of gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!
  

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