BioNTech SE
Engineer IT Compliance(m/w/x)
Vollzeitnur vor OrtBerufserfahren
Mainz
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
BIBioNTech SE
Associate Director Digital Systems Compliance(m/w/x)
Mainz, München
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Defining validation strategies for clinical systems at a biotech firm. 8+ years in validation/quality, ideally pharma/biotech, required. Focus on regulatory compliance and computer system lifecycle.
Anforderungen
- Bachelor’s degree in Information Systems, Medical, Pharmaceutical or Biomedical sciences
- 8+ years experience in validation/quality, ideally in pharmaceutical/biotech industry
- Knowledge in computer system lifecycle, CSV/CSA, IT controls in regulated environment
- Well versed with CSV/CSA regulations (21 CFR 11, Annex 11, EMA, ICH, CSA Guidance)
- Knowledge of IT Control methodologies, solid understanding of GxP guidance
- IT knowledge (access control, account setup, file permission, database, cloud)
- Good understanding of validation principles, practices, and risk-based approach
- Ability to work in multidisciplinary team, operate effectively in matrix environment, team player, able to work independently
Aufgaben
- Define and implement validation strategies for clinical systems
- Ensure compliance with organizational and regulatory standards
- Drive regulatory compliance through audit readiness and training
- Conduct access reviews and gather regulatory intelligence
- Create and manage validation documents according to SOPs
- Apply technical, functional, business, and industry knowledge
- Guide teams and support decision-making within the department
- Drive complex projects across departments
- Act as the main point of contact for validation issues
- Collaborate with stakeholders to support the audit process
- Oversee quality investigations
- Contribute to the department’s strategic direction
- Focus on continuous improvement
- Leverage technical expertise to address complex validation challenges
- Implement compliant and effective solutions
- Enhance cross-functional efficiency
- Maintain regulatory standards
- Guide projects spanning multiple groups
- Influence project direction
- Allocate validation resources for successful outcomes
- Run audit readiness program to ensure inspection readiness
- Reduce potential findings
Berufserfahrung
- 8 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- CSV
- CSA
- 21 CFR 11
- Annex 11
- EMA
- ICH Guidelines
- GxP
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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VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Defining validation strategies for clinical systems at a biotech firm. 8+ years in validation/quality, ideally pharma/biotech, required. Focus on regulatory compliance and computer system lifecycle.
Anforderungen
- Bachelor’s degree in Information Systems, Medical, Pharmaceutical or Biomedical sciences
- 8+ years experience in validation/quality, ideally in pharmaceutical/biotech industry
- Knowledge in computer system lifecycle, CSV/CSA, IT controls in regulated environment
- Well versed with CSV/CSA regulations (21 CFR 11, Annex 11, EMA, ICH, CSA Guidance)
- Knowledge of IT Control methodologies, solid understanding of GxP guidance
- IT knowledge (access control, account setup, file permission, database, cloud)
- Good understanding of validation principles, practices, and risk-based approach
- Ability to work in multidisciplinary team, operate effectively in matrix environment, team player, able to work independently
Aufgaben
- Define and implement validation strategies for clinical systems
- Ensure compliance with organizational and regulatory standards
- Drive regulatory compliance through audit readiness and training
- Conduct access reviews and gather regulatory intelligence
- Create and manage validation documents according to SOPs
- Apply technical, functional, business, and industry knowledge
- Guide teams and support decision-making within the department
- Drive complex projects across departments
- Act as the main point of contact for validation issues
- Collaborate with stakeholders to support the audit process
- Oversee quality investigations
- Contribute to the department’s strategic direction
- Focus on continuous improvement
- Leverage technical expertise to address complex validation challenges
- Implement compliant and effective solutions
- Enhance cross-functional efficiency
- Maintain regulatory standards
- Guide projects spanning multiple groups
- Influence project direction
- Allocate validation resources for successful outcomes
- Run audit readiness program to ensure inspection readiness
- Reduce potential findings
Berufserfahrung
- 8 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- CSV
- CSA
- 21 CFR 11
- Annex 11
- EMA
- ICH Guidelines
- GxP
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.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
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?
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