BioNTech SE
Associate Director SCM Compliance(m/w/x)
Full-timeOn-siteSenior
Mainz
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BIBioNTech SE
Associate Director Digital Systems Compliance(m/w/x)
Mainz, München
Full-timeOn-siteSenior
Nejo AI Summary
Defining and implementing validation strategies for clinical systems in biotechnology. 8+ years validation/quality experience in pharmaceutical/biotech required. High degree of autonomy.
Requirements
- 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
Tasks
- 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
Work Experience
- 8 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
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
Associate Director Digital Systems Compliance(m/w/x)
Mainz, München
Full-timeOn-siteSenior
Nejo AI Summary
Defining and implementing validation strategies for clinical systems in biotechnology. 8+ years validation/quality experience in pharmaceutical/biotech required. High degree of autonomy.
Requirements
- 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
Tasks
- 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
Work Experience
- 8 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
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?
- BioNTech SE
Associate Director SCM Compliance(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Associate Director IT Infrastructure Services(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Engineer Compliance CSV & DI(m/w/x)
Full-timeOn-siteExperiencedMainz - BioNTech SE
Engineer ERP Validation(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Manager QA Compliance(m/w/x)
Full-timeOn-siteSeniorMainz