BioNTech SE
Specialist QA Compliance(m/w/x)
Full-timeOn-siteExperienced
Mainz
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Global quality system oversight for pharmaceutical product development. Extensive GMP experience, MAH/Sponsor QMS management required. Vacation account, flexible hours.
Requirements
- Degree in Pharmacy, Chemistry, Biology, or related field
- Advanced degrees (MSc, PhD) as a plus
- Extensive experience in Quality Assurance and GMP
- Management of MAH/Sponsor responsibilities and QMS
- Knowledge of GMP, ICH Q10, and regulations
- Exceptional communication and networking skills
- Excellent written and verbal English skills
- Analytical mindset and compliance problem-solving ability
Tasks
- Oversee the global MAH and Sponsor QMS footprint
- Design and optimize the compliance process landscape
- Advise strategic partners on complex GMP matters
- Organize and support Quality forums and committees
- Provide compliance guidance to internal stakeholders
- Improve quality systems per GMP and ICH guidelines
- Represent the company to ensure regional compliance
- Implement board processes for evaluating quality metrics
- Report on trends and mitigate compliance risks
- Coordinate and support regulatory inspections and audits
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- GMP compliance
- QMS frameworks
- ICH Q10
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
Informal Culture
- Culture on an equal footing
Purpose-Driven Work
- Opportunities to shape and impact
Mentorship & Coaching
- Support for your full potential
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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Global quality system oversight for pharmaceutical product development. Extensive GMP experience, MAH/Sponsor QMS management required. Vacation account, flexible hours.
Requirements
- Degree in Pharmacy, Chemistry, Biology, or related field
- Advanced degrees (MSc, PhD) as a plus
- Extensive experience in Quality Assurance and GMP
- Management of MAH/Sponsor responsibilities and QMS
- Knowledge of GMP, ICH Q10, and regulations
- Exceptional communication and networking skills
- Excellent written and verbal English skills
- Analytical mindset and compliance problem-solving ability
Tasks
- Oversee the global MAH and Sponsor QMS footprint
- Design and optimize the compliance process landscape
- Advise strategic partners on complex GMP matters
- Organize and support Quality forums and committees
- Provide compliance guidance to internal stakeholders
- Improve quality systems per GMP and ICH guidelines
- Represent the company to ensure regional compliance
- Implement board processes for evaluating quality metrics
- Report on trends and mitigate compliance risks
- Coordinate and support regulatory inspections and audits
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- GMP compliance
- QMS frameworks
- ICH Q10
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
Informal Culture
- Culture on an equal footing
Purpose-Driven Work
- Opportunities to shape and impact
Mentorship & Coaching
- Support for your full potential
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
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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Senior Director Protein Modality Lead(m/w/x)
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Quality Assurance Manager Product Life Cycle Management(m/w/x)
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