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Manager Global Quality Assurance CSV

Mainz, Germany   |   full time   |   Job ID: 11236 

 

 

About the Role:

As part of the global QA team, this role is responsible to support the validation of global computerized system in the BioNTech network. 

 

Your Contribution:

  • You will support global validation projects of from a QA perspective to ensure that corporate computerized systems are validated and meet BioNTech's quality system and current regulatory requirements
  • You will oversee pharmaceutical quality system processes (e.g., CAPA, deviation, change control, training) for corporate GxP-critical applications, IT infrastructure, and projects, ensuring effective collaboration between global and local levels
  • You will support the development, harmonization, optimization, and maintenance of CSV-related quality processes globally and across multiple manufacturing sites and areas, including Global Standards/Policies and SOPs, ensuring compliance with applicable regulatory requirements
  • You will contribute to audit and inspection readiness within your area of responsibility, presenting global QA oversight and validation activities and processes during inspections

 

A Good Match:

  • You hold a degree in pharmacy, chemistry, biology, or a related scientific field, or equivalent industrial qualification and experience
  • At least 3 years of experience in Quality Assurance, particularly in Computer System Validation (CSV) / Computer System Assurance (CSA) and Data Integrity
  • You have a solid understanding of GxP regulations and pharmaceutical quality systems, with experience in global and local project environments
  • You have hands-on experience in validation of systems like SAP, Laboratory Information Sysmtems (LIMS), and Manufacturing Execution Systems (MES)
  • You have first audit experience and demonstrate strong analytical and proactive capabilities, as well as strong problem-solving skills to effectively drive quality improvements
  • You are motivated to work in an agile environment, embracing change and continuous improvement
  • You are analytical and proactive, with strong problem-solving skills to drive quality improvements effectively
  • You are fluent in English, and proficiency in German is considered a plus

 

 

Your Benefits:

 

It's our priority to support you:

  • Your flexibility: flexible hours | vacation account  
  • Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
  • Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
  • Your health and lifestyle: Company bike
  • Your mobility: Job ticket | Deutschlandticket 
  • Your life phases: Employer-funded pension | Childcare 

 

 

Apply now - We look forward to your application!

 

Apply to our Mainz, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 1 PM to 3 PM CET).

 

Job ID 11236 (please always specify if you have any questions)   

 

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.

 

Inspired? Become part of #TeamBioNTech. 

BioNTech, the story 

At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.  

Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine.  

Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world. 

BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!  

BioNTech - As unique as you 

www.biontech.com  

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