Die KI-Suchmaschine für Jobs
Functional Lead QA CSV(m/w/x)
Beschreibung
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.
Lass KI die perfekten Jobs für dich finden!
Lade deinen CV hoch und die Nejo-KI findet passende Stellenangebote für dich.
Anforderungen
- •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
Ausbildung
Berufserfahrung
ca. 4 - 6 Jahre
Aufgaben
- •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 & Technologien
Sprachen
Englisch – verhandlungssicher
Deutsch – verhandlungssicher
Benefits
Boni & Prämien
- •Performance-based compensation programs
Mitarbeiterrabatte
- •Lifestyle benefits
- •Leisure benefits
Familienfreundlichkeit
- •Family benefits
Weiterbildungsangebote
- •Agile career opportunities
Startup-Atmosphäre
- •Dynamic work culture
Sinnstiftende Arbeit
- •Inclusive and ethical workplace
Sonstige Vorteile
- •Relocation assistance
- LonzaVollzeitnur vor OrtSeniorVisp
- CH12 Lonza AG
CSV Engineer(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Lonza
Head of CQV/CSV - Advanced Synthesis Conjugates(m/w/x)
Vollzeitnur vor OrtSeniorVisp - CH12 Lonza AG
Junior CSV Engineer(m/w/x)
Vollzeitnur vor OrtJuniorVisp - Lonza
Senior QA Specialist - Qualification/Validation/EM (Environmental Monitoring)(m/w/x)
Vollzeitnur vor OrtSeniorVisp
Functional Lead QA CSV(m/w/x)
Die KI-Suchmaschine für Jobs
Beschreibung
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.
Lass KI die perfekten Jobs für dich finden!
Lade deinen CV hoch und die Nejo-KI findet passende Stellenangebote für dich.
Anforderungen
- •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
Ausbildung
Berufserfahrung
ca. 4 - 6 Jahre
Aufgaben
- •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 & Technologien
Sprachen
Englisch – verhandlungssicher
Deutsch – verhandlungssicher
Benefits
Boni & Prämien
- •Performance-based compensation programs
Mitarbeiterrabatte
- •Lifestyle benefits
- •Leisure benefits
Familienfreundlichkeit
- •Family benefits
Weiterbildungsangebote
- •Agile career opportunities
Startup-Atmosphäre
- •Dynamic work culture
Sinnstiftende Arbeit
- •Inclusive and ethical workplace
Sonstige Vorteile
- •Relocation assistance
Über das Unternehmen
Lonza
Branche
Pharmaceuticals
Beschreibung
Lonza is a global leader in life sciences, committed to improving lives through innovative solutions and ethical practices.
- Lonza
Team Lead CSV Biologics(m/w/x)
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CSV Engineer(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Lonza
Head of CQV/CSV - Advanced Synthesis Conjugates(m/w/x)
Vollzeitnur vor OrtSeniorVisp - CH12 Lonza AG
Junior CSV Engineer(m/w/x)
Vollzeitnur vor OrtJuniorVisp - Lonza
Senior QA Specialist - Qualification/Validation/EM (Environmental Monitoring)(m/w/x)
Vollzeitnur vor OrtSeniorVisp