BioNTech SE
Associate Director Audit Management(m/w/x)
Full-timeOn-siteSenior
Mainz, München
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BIBioNTech SE
Associate Director Digital Systems Compliance(m/w/x)
Mainz, München
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 8 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- CSV
- CSA
- 21 CFR 11
- Annex 11
- EMA
- ICH Guidelines
- GxP
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 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.
Requirements
- 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
Tasks
- 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
Work Experience
- 8 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- CSV
- CSA
- 21 CFR 11
- Annex 11
- EMA
- ICH Guidelines
- GxP
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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
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 Audit Management(m/w/x)
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Associate Director Biostatistics(m/w/x)
Full-timeOn-siteSeniorMainz