BioNTech SE
Executive Director Manufacturing Network QA(m/w/x)
Vollzeitnur vor OrtSenior
Mainz
Neuer Job?Nejo!
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BIBioNTech SE
Senior Director Global Quality Supply(m/w/x)
Mainz
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 10 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- DSCSA
- FMD
- FDA
- EMA
- WHO
- GDP
- GMP
Benefits
Flexibles Arbeiten
- Flexible hours
Mehr Urlaubstage
- Vacation account
Weiterbildungsangebote
- Digital Learning
- LinkedIn Learning
Karriere- und Weiterentwicklung
- Performance and talent development
- Leadership development
Sonstige Vorteile
- Apprenticeships
- Support for your full potential
Startup-Atmosphäre
- Voice at the table
Lockere Unternehmenskultur
- Culture on an equal footing
Sinnstiftende Arbeit
- Opportunities to shape and impact
Firmenfahrrad
- Company bike
Öffi Tickets
- Job ticket
- Deutschlandticket
Betriebliche Altersvorsorge
- Employer-funded pension
Kinderbetreuung
- Childcare
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens BioNTech SE erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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BIBioNTech SE
Senior Director Global Quality Supply(m/w/x)
Mainz
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 10 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- DSCSA
- FMD
- FDA
- EMA
- WHO
- GDP
- GMP
Benefits
Flexibles Arbeiten
- Flexible hours
Mehr Urlaubstage
- Vacation account
Weiterbildungsangebote
- Digital Learning
- LinkedIn Learning
Karriere- und Weiterentwicklung
- Performance and talent development
- Leadership development
Sonstige Vorteile
- Apprenticeships
- Support for your full potential
Startup-Atmosphäre
- Voice at the table
Lockere Unternehmenskultur
- Culture on an equal footing
Sinnstiftende Arbeit
- Opportunities to shape and impact
Firmenfahrrad
- Company bike
Öffi Tickets
- Job ticket
- Deutschlandticket
Betriebliche Altersvorsorge
- Employer-funded pension
Kinderbetreuung
- Childcare
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens BioNTech SE erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
BioNTech SE
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen entwickelt bahnbrechende Medikamente zur Verbesserung der globalen Gesundheit und zur Bekämpfung von Krankheiten.
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