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Senior Director Protein Modality Lead(m/w/x)
Leading data-driven Quality Assurance for protein-based medicines, ensuring QMS/GMP adherence. Extensive R&D/Product Quality experience with deep ICH guidelines understanding required. Flexible hours, vacation account.
Anforderungen
- Degree in Life Sciences, Pharmacy, Chemistry, Engineering, or related field
- Advanced degrees (e.g., MSc, PhD, MBA) highly desirable
- Extensive experience in R&D Quality or Product Quality
- Deep understanding of ICH guidelines (Q8, Q9, Q10)
- Long-term business and pharmaceutical understanding
- Proven ability to lead and develop teams
- Exceptional analytical and problem-solving skills
- Excellent communication and interpersonal skills
Aufgaben
- Build and lead a data-driven team
- Develop and implement a metric-driven leadership approach for protein-based products
- Ensure alignment with risk management principles and regulatory guidelines
- Provide leadership for protein-based products from a Quality Assurance perspective
- Ensure phase-appropriate development while adhering to QMS and GMP standards
- Oversee critical product changes related to regulatory compliance and quality
- Guide changes across the product lifecycle for safety, efficacy, and manufacturing
- Manage critical product deviations impacting compliance and quality
- Lead thorough investigations and resolutions of product deviations
- Communicate deviations to mitigate risks and maintain compliance
- Foster a culture of collaboration and accountability within the team
- Focus on team development and alignment with organizational priorities
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Flexibles Arbeiten
- Flexible hours
Mehr Urlaubstage
- Vacation account
Weiterbildungsangebote
- Digital learning
- Apprenticeships
- LinkedIn learning
Karriere- und Weiterentwicklung
- Performance and talent development
- Leadership development
Sonstige Vorteile
- Your voice at the table
- Support for your full potential
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
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Senior Director Protein Modality Lead(m/w/x)
Leading data-driven Quality Assurance for protein-based medicines, ensuring QMS/GMP adherence. Extensive R&D/Product Quality experience with deep ICH guidelines understanding required. Flexible hours, vacation account.
Anforderungen
- Degree in Life Sciences, Pharmacy, Chemistry, Engineering, or related field
- Advanced degrees (e.g., MSc, PhD, MBA) highly desirable
- Extensive experience in R&D Quality or Product Quality
- Deep understanding of ICH guidelines (Q8, Q9, Q10)
- Long-term business and pharmaceutical understanding
- Proven ability to lead and develop teams
- Exceptional analytical and problem-solving skills
- Excellent communication and interpersonal skills
Aufgaben
- Build and lead a data-driven team
- Develop and implement a metric-driven leadership approach for protein-based products
- Ensure alignment with risk management principles and regulatory guidelines
- Provide leadership for protein-based products from a Quality Assurance perspective
- Ensure phase-appropriate development while adhering to QMS and GMP standards
- Oversee critical product changes related to regulatory compliance and quality
- Guide changes across the product lifecycle for safety, efficacy, and manufacturing
- Manage critical product deviations impacting compliance and quality
- Lead thorough investigations and resolutions of product deviations
- Communicate deviations to mitigate risks and maintain compliance
- Foster a culture of collaboration and accountability within the team
- Focus on team development and alignment with organizational priorities
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Flexibles Arbeiten
- Flexible hours
Mehr Urlaubstage
- Vacation account
Weiterbildungsangebote
- Digital learning
- Apprenticeships
- LinkedIn learning
Karriere- und Weiterentwicklung
- Performance and talent development
- Leadership development
Sonstige Vorteile
- Your voice at the table
- Support for your full potential
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
Über das Unternehmen
BioNTech SE
Branche
Healthcare
Beschreibung
Das Unternehmen entwickelt bahnbrechende Medikamente zur Verbesserung der globalen Gesundheit und zur Bekämpfung von Krankheiten.
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