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Functional Lead QA CSV(m/w/x)
Description
As a functional lead, you will drive site-wide CSV governance and data integrity. You'll balance strategic decision-making with hands-on project oversight to ensure the site remains inspection-ready.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
Requirements
- •Degree in Computer Science, Engineering, Life Sciences or similar
- •Experience in pharma/biotech QA, CSV and Data Integrity
- •Knowledge of GxP, Annex 11, 21 CFR Part 11 and GAMP 5
- •Understanding of system lifecycle and computerized systems
- •Strategic mindset, decision-making and stakeholder alignment skills
- •Experience in audits/inspections related to CSV & DI
- •Excellent communication skills in English & German
Education
Work Experience
approx. 4 - 6 years
Tasks
- •Define and maintain the site CSV strategy
- •Align strategies with global standards and regulatory requirements
- •Act as the QA CSV authority in projects
- •Ensure compliant system lifecycle management
- •Evaluate digital technologies for CSV and Data Integrity controls
- •Drive harmonization and global alignment of CSV processes
- •Make strategic decisions on CSV risks and validation approaches
- •Present local CSV strategies during audits and inspections
- •Approve key CSV deliverables and inspection-ready documentation
- •Provide SME support and cross-functional guidance
Tools & Technologies
Languages
English – Business Fluent
German – Business Fluent
Benefits
Bonuses & Incentives
- •Performance-based compensation programs
Corporate Discounts
- •Lifestyle benefits
- •Leisure benefits
Family Support
- •Family benefits
Learning & Development
- •Agile career opportunities
Startup Environment
- •Dynamic work culture
Purpose-Driven Work
- •Inclusive and ethical workplace
Other Benefits
- •Relocation assistance
- LonzaFull-timeOn-siteSeniorVisp
- CH12 Lonza AG
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Functional Lead QA CSV(m/w/x)
The AI Job Search Engine
Description
As a functional lead, you will drive site-wide CSV governance and data integrity. You'll balance strategic decision-making with hands-on project oversight to ensure the site remains inspection-ready.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
Requirements
- •Degree in Computer Science, Engineering, Life Sciences or similar
- •Experience in pharma/biotech QA, CSV and Data Integrity
- •Knowledge of GxP, Annex 11, 21 CFR Part 11 and GAMP 5
- •Understanding of system lifecycle and computerized systems
- •Strategic mindset, decision-making and stakeholder alignment skills
- •Experience in audits/inspections related to CSV & DI
- •Excellent communication skills in English & German
Education
Work Experience
approx. 4 - 6 years
Tasks
- •Define and maintain the site CSV strategy
- •Align strategies with global standards and regulatory requirements
- •Act as the QA CSV authority in projects
- •Ensure compliant system lifecycle management
- •Evaluate digital technologies for CSV and Data Integrity controls
- •Drive harmonization and global alignment of CSV processes
- •Make strategic decisions on CSV risks and validation approaches
- •Present local CSV strategies during audits and inspections
- •Approve key CSV deliverables and inspection-ready documentation
- •Provide SME support and cross-functional guidance
Tools & Technologies
Languages
English – Business Fluent
German – Business Fluent
Benefits
Bonuses & Incentives
- •Performance-based compensation programs
Corporate Discounts
- •Lifestyle benefits
- •Leisure benefits
Family Support
- •Family benefits
Learning & Development
- •Agile career opportunities
Startup Environment
- •Dynamic work culture
Purpose-Driven Work
- •Inclusive and ethical workplace
Other Benefits
- •Relocation assistance
About the Company
Lonza
Industry
Pharmaceuticals
Description
Lonza is a global leader in life sciences, committed to improving lives through innovative solutions and ethical practices.
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