BioNTech SE
Associate Director IT Infrastructure Services(m/w/x)
Vollzeitnur vor OrtSenior
Mainz
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BIBioNTech SE
Associate Director Digital Systems Compliance(m/w/x)
Mainz, München
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Defining and implementing validation strategies for clinical systems in biotechnology. 8+ years validation/quality experience in pharmaceutical/biotech required. High degree of autonomy.
Anforderungen
- Bachelor’s degree in Information Systems, Medical, Pharmaceutical or Biomedical sciences
- 8+ years’ experience in validation/quality, ideally in pharmaceutical/biotech industry
- Knowledge of computer system lifecycle activities, CSV/CSA, IT controls in regulated environment
- Familiarity with CSV/CSA regulations (21 CFR 11, Annex 11, EMA, ICH Guidelines, CSA Guidance)
- Knowledge of IT Control methodologies and GxP guidance
- IT knowledge (access control, account setup, file permission, database, cloud)
- Good understanding of validation principles, practices, and risk-based approach
- Teamwork with multidisciplinary scientists/IT, effective matrix environment operation, independent work ability
Aufgaben
- Define validation strategies for clinical systems
- Implement validation strategies for clinical systems
- Ensure compliance with organizational and regulatory standards
- Ensure audit readiness for digital systems
- Ensure training compliance for digital systems
- Conduct access reviews for digital systems
- Utilize regulatory intelligence for digital systems
- Create validation documents per SOPs and regulations
- Manage validation documents per SOPs and regulations
- Guide teams with technical and functional expertise
- Support decision-making with business and industry knowledge
- Drive complex cross-departmental projects aligned with objectives
- Serve as main contact for validation issues
- Collaborate with diverse stakeholders
- Support the audit process
- Oversee quality investigations
- Contribute to strategic direction for continuous improvement
- Address complex validation challenges across clinical systems
- Implement innovative solutions using conceptual thinking
- Enhance cross-functional efficiency
- Maintain regulatory standards
- Guide multi-group projects for successful outcomes
- Influence project direction and allocate resources
- Run the Audit Readiness Program
- Prepare the department for inspections
- Reduce potential audit findings
Berufserfahrung
- 8 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens BioNTech SE erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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BIBioNTech SE
Associate Director Digital Systems Compliance(m/w/x)
Mainz, München
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Defining and implementing validation strategies for clinical systems in biotechnology. 8+ years validation/quality experience in pharmaceutical/biotech required. High degree of autonomy.
Anforderungen
- Bachelor’s degree in Information Systems, Medical, Pharmaceutical or Biomedical sciences
- 8+ years’ experience in validation/quality, ideally in pharmaceutical/biotech industry
- Knowledge of computer system lifecycle activities, CSV/CSA, IT controls in regulated environment
- Familiarity with CSV/CSA regulations (21 CFR 11, Annex 11, EMA, ICH Guidelines, CSA Guidance)
- Knowledge of IT Control methodologies and GxP guidance
- IT knowledge (access control, account setup, file permission, database, cloud)
- Good understanding of validation principles, practices, and risk-based approach
- Teamwork with multidisciplinary scientists/IT, effective matrix environment operation, independent work ability
Aufgaben
- Define validation strategies for clinical systems
- Implement validation strategies for clinical systems
- Ensure compliance with organizational and regulatory standards
- Ensure audit readiness for digital systems
- Ensure training compliance for digital systems
- Conduct access reviews for digital systems
- Utilize regulatory intelligence for digital systems
- Create validation documents per SOPs and regulations
- Manage validation documents per SOPs and regulations
- Guide teams with technical and functional expertise
- Support decision-making with business and industry knowledge
- Drive complex cross-departmental projects aligned with objectives
- Serve as main contact for validation issues
- Collaborate with diverse stakeholders
- Support the audit process
- Oversee quality investigations
- Contribute to strategic direction for continuous improvement
- Address complex validation challenges across clinical systems
- Implement innovative solutions using conceptual thinking
- Enhance cross-functional efficiency
- Maintain regulatory standards
- Guide multi-group projects for successful outcomes
- Influence project direction and allocate resources
- Run the Audit Readiness Program
- Prepare the department for inspections
- Reduce potential audit findings
Berufserfahrung
- 8 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens BioNTech SE erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
BioNTech SE
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen entwickelt bahnbrechende Medikamente zur Verbesserung der globalen Gesundheit und zur Bekämpfung von Krankheiten.
Noch nicht perfekt?
- BioNTech SE
Associate Director IT Infrastructure Services(m/w/x)
Vollzeitnur vor OrtSeniorMainz - BioNTech SE
Associate Director SCM Compliance(m/w/x)
Vollzeitnur vor OrtSeniorMainz - BioNTech SE
Engineer Compliance CSV & DI(m/w/x)
Vollzeitnur vor OrtBerufserfahrenMainz - BioNTech SE
Engineer ERP Validation(m/w/x)
Vollzeitnur vor OrtSeniorMainz - BioNTech SE
Manager QA Compliance(m/w/x)
Vollzeitnur vor OrtSeniorMainz