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BIBioNTech SE

Associate Director Digital Systems Compliance(m/w/x)

Mainz, München
Full-timeOn-siteSenior
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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
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