BioNTech SE
Manager QA Compliance(m/w/x)
Full-timeOn-siteSenior
Mainz
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BIBioNTech SE
.Manager Global Quality Assurance CSV(m/w/x)
Mainz
Full-timeOn-siteExperienced
Nejo AI Summary
Global validation support for GxP-critical applications, ensuring regulatory compliance for SAP, LIMS, and MES. 3+ years of CSV/CSA and Data Integrity experience required. Flexible hours, vacation account, digital learning.
Requirements
- Degree in pharmacy, chemistry, biology, or related scientific field, or equivalent industrial qualification and experience
- At least 3 years of experience in Quality Assurance, particularly in Computer System Validation (CSV) / Computer System Assurance (CSA) and Data Integrity
- Solid understanding of GxP regulations and pharmaceutical quality systems, with experience in global and local project environments
- Hands-on experience in validation of systems like SAP, Laboratory Information Systems (LIMS), and Manufacturing Execution Systems (MES)
- First audit experience and strong analytical and proactive capabilities, as well as strong problem-solving skills to effectively drive quality improvements
- Motivation to work in an agile environment, embracing change and continuous improvement
- Analytical and proactive, with strong problem-solving skills to drive quality improvements effectively
- Fluent in English, with proficiency in German considered a plus
Tasks
- Support global validation projects from QA perspective
- Ensure corporate computerized systems meet quality and regulatory requirements
- Oversee pharmaceutical quality system processes for GxP-critical applications
- Ensure effective collaboration between global and local levels
- Develop and maintain CSV-related quality processes globally
- Harmonize and optimize CSV processes across manufacturing sites
- Ensure compliance with regulatory requirements
- Contribute to audit and inspection readiness
- Present global QA oversight and validation activities during inspections
Work Experience
- 3 years
Education
- Bachelor's degree
Languages
- English – Fluent
- German – Basic
Tools & Technologies
- SAP
- LIMS
- MES
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
- Support for your full potential
Startup Environment
- Voice at the table
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
.Manager Global Quality Assurance CSV(m/w/x)
Mainz
Full-timeOn-siteExperienced
Nejo AI Summary
Global validation support for GxP-critical applications, ensuring regulatory compliance for SAP, LIMS, and MES. 3+ years of CSV/CSA and Data Integrity experience required. Flexible hours, vacation account, digital learning.
Requirements
- Degree in pharmacy, chemistry, biology, or related scientific field, or equivalent industrial qualification and experience
- At least 3 years of experience in Quality Assurance, particularly in Computer System Validation (CSV) / Computer System Assurance (CSA) and Data Integrity
- Solid understanding of GxP regulations and pharmaceutical quality systems, with experience in global and local project environments
- Hands-on experience in validation of systems like SAP, Laboratory Information Systems (LIMS), and Manufacturing Execution Systems (MES)
- First audit experience and strong analytical and proactive capabilities, as well as strong problem-solving skills to effectively drive quality improvements
- Motivation to work in an agile environment, embracing change and continuous improvement
- Analytical and proactive, with strong problem-solving skills to drive quality improvements effectively
- Fluent in English, with proficiency in German considered a plus
Tasks
- Support global validation projects from QA perspective
- Ensure corporate computerized systems meet quality and regulatory requirements
- Oversee pharmaceutical quality system processes for GxP-critical applications
- Ensure effective collaboration between global and local levels
- Develop and maintain CSV-related quality processes globally
- Harmonize and optimize CSV processes across manufacturing sites
- Ensure compliance with regulatory requirements
- Contribute to audit and inspection readiness
- Present global QA oversight and validation activities during inspections
Work Experience
- 3 years
Education
- Bachelor's degree
Languages
- English – Fluent
- German – Basic
Tools & Technologies
- SAP
- LIMS
- MES
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
- Support for your full potential
Startup Environment
- Voice at the table
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
Pharmaceuticals
Description
Das Unternehmen entwickelt bahnbrechende Medikamente zur Verbesserung der globalen Gesundheit und zur Bekämpfung von Krankheiten.
Not a perfect match?
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