Specialist Operational Quality Assurance - Digitalization

Specialist Operational Quality Assurance - Digitalization

Mainz, Germany | full time | Job ID:8605

As a Specialist Operational Quality Assurance - Digitalization, you will be responsible for the digitalization of GMP relevant data on a risk-based approach, setting up automated information workflows, and identifying data that requires digitalization. You will work closely with the Manager Operational Quality Assurance - Digitalization (all genders) and support them in their responsibilities within the company and towards authorities and sponsors.

Your main responsibilities are:

• Digitalize GMP relevant data on a risk-based approach
• Identify data which requires digitalization
• Setup automated information workflows and applications
• Support the Manager Operational Quality Assurance - Digitalization (all genders) in representing QA topics in the field of work towards authorities and sponsors
• Provide preparation and support for routine reporting into quality management

What You Have to Offer:

• University degree or proven equivalent experience in computer science, data science/engineering, information systems, big data management or AI science/engineering
• Experience in digital transformation of business processes, ideally in the GMP environment
• First experience with AI and Large Language Models and programming skills
• Knowledge of tools and technologies used for automating workflows and processes (e.g. MS Power Platform)
• Understanding of data management practices and standards (e.g. data architecture, data quality, metadata management)
• Experience in collaborating with interdisciplinary teams and representing QA topics to internal and external stakeholders
• Knowledge of statistical methods and analysis tools for data analysis and evaluation
• Quality mindset and knowledge of EU GMP and FDA regulations and FAIR and ALCOA+ principles
• Strong communication and presentation skills in both German and English
• Team spirit and collaborating skills

It's our priority to support you:

• Your flexibility: flexible hours | vacation account
• 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 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 12 PM to 4 PM CET).

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.

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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!