BioNTech SE
.Manager Global Quality Assurance CSV(m/w/x)
Full-timeOn-siteExperienced
Mainz
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BIBioNTech SE
Manager Systems Quality Assurance(m/w/x)
Mainz
Full-timeOn-siteExperienced
Nejo AI Summary
Negotiating quality contracts with CMOs and supporting supplier qualification for biotech drug development. Deep expertise in QA agreements and US/EU regulations required. Flexible hours, vacation account, and leadership development.
Requirements
- Professional experience (>3 years) in pharmaceutical industry, preferably QA/QM
- Quality mindset and profound knowledge of US & EU regulations (EMA, FDA, ICH, GDP)
- Deep expertise in negotiation of quality assurance agreements
- Experience supporting manufacturing of investigational and commercial products
- Resilient personality, ability to connect people and distribute information
- Good strategic skills and ability to make profound decisions
- Strong communication, collaboration, and diplomacy skills in German and English
- High team spirit, effective stakeholder management and collaboration skills
Tasks
- Negotiate quality contracts with contract manufacturing organizations
- Support supplier qualification and oversight
- Create and maintain quality assurance agreements
- Review and revise agreements periodically
- Coordinate with internal and external stakeholders
- Train operational departments on quality assurance agreements
- Participate in building a robust supply chain
- Optimize processes within the contract lifecycle
- Evaluate and process external documents and notifications
- Communicate with operational teams
- Align with local and global stakeholder groups
Work Experience
- 3 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- US & EU regulations
- EMA
- FDA
- EU-GMP
- 21 CFR Part 211
- ICH Guidelines
- GDP
Benefits
Flexible Working
- Flexible hours
More Vacation Days
- Vacation account
Learning & Development
- Digital Learning
- LinkedIn Learning
Career Advancement
- Performance and talent development
- Leadership development
Other Benefits
- Apprenticeships
- Support for your full potential
Startup Environment
- Voice at the table
Informal Culture
- Culture on an equal footing
Purpose-Driven Work
- Opportunities to shape and impact
Company Bike
- Company bike
Public Transport Subsidies
- Job ticket
- Deutschlandticket
Retirement Plans
- Employer-funded pension
Childcare
- Childcare
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BioNTech SE and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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BIBioNTech SE
Manager Systems Quality Assurance(m/w/x)
Mainz
Full-timeOn-siteExperienced
Nejo AI Summary
Negotiating quality contracts with CMOs and supporting supplier qualification for biotech drug development. Deep expertise in QA agreements and US/EU regulations required. Flexible hours, vacation account, and leadership development.
Requirements
- Professional experience (>3 years) in pharmaceutical industry, preferably QA/QM
- Quality mindset and profound knowledge of US & EU regulations (EMA, FDA, ICH, GDP)
- Deep expertise in negotiation of quality assurance agreements
- Experience supporting manufacturing of investigational and commercial products
- Resilient personality, ability to connect people and distribute information
- Good strategic skills and ability to make profound decisions
- Strong communication, collaboration, and diplomacy skills in German and English
- High team spirit, effective stakeholder management and collaboration skills
Tasks
- Negotiate quality contracts with contract manufacturing organizations
- Support supplier qualification and oversight
- Create and maintain quality assurance agreements
- Review and revise agreements periodically
- Coordinate with internal and external stakeholders
- Train operational departments on quality assurance agreements
- Participate in building a robust supply chain
- Optimize processes within the contract lifecycle
- Evaluate and process external documents and notifications
- Communicate with operational teams
- Align with local and global stakeholder groups
Work Experience
- 3 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- US & EU regulations
- EMA
- FDA
- EU-GMP
- 21 CFR Part 211
- ICH Guidelines
- GDP
Benefits
Flexible Working
- Flexible hours
More Vacation Days
- Vacation account
Learning & Development
- Digital Learning
- LinkedIn Learning
Career Advancement
- Performance and talent development
- Leadership development
Other Benefits
- Apprenticeships
- Support for your full potential
Startup Environment
- Voice at the table
Informal Culture
- Culture on an equal footing
Purpose-Driven Work
- Opportunities to shape and impact
Company Bike
- Company bike
Public Transport Subsidies
- Job ticket
- Deutschlandticket
Retirement Plans
- Employer-funded pension
Childcare
- Childcare
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BioNTech SE and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
BioNTech SE
Industry
Pharmaceuticals
Description
Das Unternehmen entwickelt bahnbrechende Medikamente zur Verbesserung der globalen Gesundheit und zur Bekämpfung von Krankheiten.
Not a perfect match?
- BioNTech SE
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Full-timeOn-siteExperiencedIngelheim am Rhein - BioNTech SE
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