Manager Systems Quality Assurance

Responsibilities

• Create, negotiate, and maintain quality assurance agreements with national and international partners, including CMOs and laboratories.
• Coordinate with internal and external stakeholders to ensure effective supplier qualification and oversight.
• Train operational departments on the contents and requirements of quality assurance agreements.
• Support the optimization of processes within the contract lifecycle to build a robust supply chain.
• Evaluate and process external documents and notifications from contract partners.
• Align with global stakeholder groups including Legal, Procurement, CMC, and Qualified Persons.

Requirements

• 3+ years of professional experience in the pharmaceutical industry, preferably in Quality Assurance or Quality Management.
• Profound knowledge of US and EU regulations (EMA, FDA) and standards such as EU-GMP, 21 CFR Part 211, ICH Guidelines, and GDP.
• Deep expertise in negotiating quality assurance agreements with external service providers.
• Experience supporting the manufacturing of investigational medicinal products (Phase I-III) and commercial products.
• Fluency in both German and English.
• Strong communication, collaboration, and stakeholder management skills.

Benefits

• Flexible working hours and a vacation account.
• Professional growth through digital learning, leadership development, and LinkedIn Learning.
• Health and lifestyle support including a company bike and job ticket/Deutschlandticket.
• Employer-funded pension and childcare support.

About the Company

BioNTech is a biotechnology company dedicated to revolutionizing medicine by translating cutting-edge science into survival. We are a community of innovators and scientists working to address high medical needs, such as cancer and infectious diseases, to improve global health.