BioNTech SE
Executive Director Manufacturing Network QA(m/w/x)
Full-timeOn-siteSenior
Mainz
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BIBioNTech SE
Senior Director Protein Modality Lead(m/w/x)
Mainz
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Benefits
Flexible Working
- Flexible hours
More Vacation Days
- Vacation account
Learning & Development
- Digital learning
- Apprenticeships
- LinkedIn learning
Career Advancement
- Performance and talent development
- Leadership development
Other Benefits
- Your voice at the table
- Support for your full potential
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 Protein Modality Lead(m/w/x)
Mainz
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Benefits
Flexible Working
- Flexible hours
More Vacation Days
- Vacation account
Learning & Development
- Digital learning
- Apprenticeships
- LinkedIn learning
Career Advancement
- Performance and talent development
- Leadership development
Other Benefits
- Your voice at the table
- Support for your full potential
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.
About the Company
BioNTech SE
Industry
Healthcare
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
Director Manufacturing Sciences & Technology(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Manager QA Compliance(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Director AS&T Projects & Strategy(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Director Process Engineering(m/w/x)
Full-timeOn-siteSeniorMainz