BioNTech SE
Manager QA Compliance(m/w/x)
Full-timeOn-siteSenior
Mainz
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BIBioNTech SE
Specialist QA Compliance(m/w/x)
Mainz
Full-timeOn-siteExperienced
Nejo AI Summary
Designing MAH/Sponsor process landscapes and advising on complex GMP matters in pharmaceutical manufacturing. 3+ years experience in GMP Compliance, QMS, and MAH/Sponsor processes required; advanced QM/RA certifications a plus. Vacation account, flexible hours.
Requirements
- Degree in Life Sciences, Pharmacy, Chemistry, or related field
- Advanced degrees or certifications in Quality Management or Regulatory Affairs (plus)
- 3+ years experience in GMP Compliance, QMS, and MAH/Sponsor processes
- Strong analytical and problem-solving skills
- Ability to interpret complex regulatory requirements
- Ability to work collaboratively in matrix organizations
- Relationship and network building skills
- Proactive approach to risk identification
- Drive for continuous improvement initiatives
- Excellent written and verbal English communication skills
- Ability to deliver training and present information
Tasks
- Design and maintain the MAH/Sponsor process landscape
- Ensure global regulatory compliance for manufacturing processes
- Advise strategic partners on complex GMP matters
- Prepare recommendations for compliance decision-making
- Coordinate and support Quality forums and committees
- Deliver compliance training to various stakeholders
- Promote a quality-driven mindset across the organization
- Support peers within the Quality matrix organization
- Collaborate with teams to resolve compliance problems
- Improve the pharmaceutical quality system per ICH guidelines
- Report on quality metrics and identify risks
- Implement mitigation strategies for operational excellence
Work Experience
- 3 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- GMP Compliance
- Quality Management Systems
- MAH/Sponsor processes
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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BIBioNTech SE
Specialist QA Compliance(m/w/x)
Mainz
Full-timeOn-siteExperienced
Nejo AI Summary
Designing MAH/Sponsor process landscapes and advising on complex GMP matters in pharmaceutical manufacturing. 3+ years experience in GMP Compliance, QMS, and MAH/Sponsor processes required; advanced QM/RA certifications a plus. Vacation account, flexible hours.
Requirements
- Degree in Life Sciences, Pharmacy, Chemistry, or related field
- Advanced degrees or certifications in Quality Management or Regulatory Affairs (plus)
- 3+ years experience in GMP Compliance, QMS, and MAH/Sponsor processes
- Strong analytical and problem-solving skills
- Ability to interpret complex regulatory requirements
- Ability to work collaboratively in matrix organizations
- Relationship and network building skills
- Proactive approach to risk identification
- Drive for continuous improvement initiatives
- Excellent written and verbal English communication skills
- Ability to deliver training and present information
Tasks
- Design and maintain the MAH/Sponsor process landscape
- Ensure global regulatory compliance for manufacturing processes
- Advise strategic partners on complex GMP matters
- Prepare recommendations for compliance decision-making
- Coordinate and support Quality forums and committees
- Deliver compliance training to various stakeholders
- Promote a quality-driven mindset across the organization
- Support peers within the Quality matrix organization
- Collaborate with teams to resolve compliance problems
- Improve the pharmaceutical quality system per ICH guidelines
- Report on quality metrics and identify risks
- Implement mitigation strategies for operational excellence
Work Experience
- 3 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- GMP Compliance
- Quality Management Systems
- MAH/Sponsor processes
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.
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