BioNTech SE
Executive Director Manufacturing Network QA(m/w/x)
Full-timeOn-siteSenior
Mainz
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BIBioNTech SE
Senior Director Global Quality Supply(m/w/x)
Mainz
Full-timeOn-siteSenior
Nejo AI Summary
Global quality strategy for packaging, labeling, serialization, storage, and distribution at a biotech firm. 10+ years pharmaceutical QA experience with commercial supply focus required. Flexible hours, vacation account, digital learning.
Requirements
- Degree in Pharmacy, Chemistry, Biotechnology, or related discipline
- 10+ years pharmaceutical QA experience with focus on commercial pharmaceutical supply (DSCSA, FMD)
- Senior-level experience in commercial packaging, labeling, serialization, storage, and distribution quality, including partner oversight
- Deep knowledge of global regulatory requirements (FDA, EMA, WHO) and industry standards (GDP, GMP), with experience implementing and maintaining compliant quality frameworks
- Ability to harmonize global processes while integrating country-specific requirements
- Ability to identify, assess, and mitigate supply chain and distribution risks, driving continuous improvement
- Leadership of global teams, cross-functional alignment, and sound, risk-based decision-making
- Effective communication with internal and external stakeholders
Tasks
- Drive global quality strategy for packaging, labeling, serialization, storage, and distribution
- Ensure inspection readiness and regulatory compliance across regions
- Provide senior QA oversight for packaging processes, artwork governance, and change management
- Lead and develop the Global Quality Supply team for consistent execution worldwide
- Establish QA governance for serialization and product traceability
- Ensure data integrity and robust processes across CMOs, depots, logistics partners, and markets
- Provide QA oversight for late-stage development transitioning into commercial supply
- Manage change controls for packaging, labeling, serialization, and distribution
- Ensure compliance and risk controls during scale-up, market expansion, and supply chain adjustments
- Oversee QA governance for storage, transportation, and distribution
- Manage cold chain management and shipping validation
- Ensure compliance with GDP, import/export regulations, and distribution licensing requirements
- Manage incidents, deviations, investigations, and CAPAs related to packaging, serialization, storage, and distribution
- Support global recalls and critical supply incidents
- Drive proactive risk management and continuous improvement aligned with ICH Q9 and ICH Q10
- Collaborate with Supply Chain Management, Commercial Operations, Regulatory Affairs, and external partners
- Define quality responsibilities and ensure accountability across the supply network through technical and quality agreements
Work Experience
- 10 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- DSCSA
- FMD
- FDA
- EMA
- WHO
- GDP
- GMP
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
Senior Director Global Quality Supply(m/w/x)
Mainz
Full-timeOn-siteSenior
Nejo AI Summary
Global quality strategy for packaging, labeling, serialization, storage, and distribution at a biotech firm. 10+ years pharmaceutical QA experience with commercial supply focus required. Flexible hours, vacation account, digital learning.
Requirements
- Degree in Pharmacy, Chemistry, Biotechnology, or related discipline
- 10+ years pharmaceutical QA experience with focus on commercial pharmaceutical supply (DSCSA, FMD)
- Senior-level experience in commercial packaging, labeling, serialization, storage, and distribution quality, including partner oversight
- Deep knowledge of global regulatory requirements (FDA, EMA, WHO) and industry standards (GDP, GMP), with experience implementing and maintaining compliant quality frameworks
- Ability to harmonize global processes while integrating country-specific requirements
- Ability to identify, assess, and mitigate supply chain and distribution risks, driving continuous improvement
- Leadership of global teams, cross-functional alignment, and sound, risk-based decision-making
- Effective communication with internal and external stakeholders
Tasks
- Drive global quality strategy for packaging, labeling, serialization, storage, and distribution
- Ensure inspection readiness and regulatory compliance across regions
- Provide senior QA oversight for packaging processes, artwork governance, and change management
- Lead and develop the Global Quality Supply team for consistent execution worldwide
- Establish QA governance for serialization and product traceability
- Ensure data integrity and robust processes across CMOs, depots, logistics partners, and markets
- Provide QA oversight for late-stage development transitioning into commercial supply
- Manage change controls for packaging, labeling, serialization, and distribution
- Ensure compliance and risk controls during scale-up, market expansion, and supply chain adjustments
- Oversee QA governance for storage, transportation, and distribution
- Manage cold chain management and shipping validation
- Ensure compliance with GDP, import/export regulations, and distribution licensing requirements
- Manage incidents, deviations, investigations, and CAPAs related to packaging, serialization, storage, and distribution
- Support global recalls and critical supply incidents
- Drive proactive risk management and continuous improvement aligned with ICH Q9 and ICH Q10
- Collaborate with Supply Chain Management, Commercial Operations, Regulatory Affairs, and external partners
- Define quality responsibilities and ensure accountability across the supply network through technical and quality agreements
Work Experience
- 10 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- DSCSA
- FMD
- FDA
- EMA
- WHO
- GDP
- GMP
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
Executive Director Manufacturing Network QA(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
.Manager Global Quality Assurance CSV(m/w/x)
Full-timeOn-siteExperiencedMainz - BioNTech SE
Manager Systems Quality Assurance(m/w/x)
Full-timeOn-siteExperiencedMainz - BioNTech SE
Director AS&T Projects & Strategy(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Director AS&T Projects & Strategy - Analytical Lead(m/w/x)
Full-timeOn-siteSeniorMainz