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BABavarian Nordic Berna GmbH

Senior QA Manager, QV & CSV(m/w/x)

Bern
Full-timeWith Home OfficeManagement

QA review and approval of qualification/validation documentation for life-saving vaccines at global vaccine developer with 30+ years experience. Extensive QV/CSV experience in pharma/biotech, with validation team leadership required. International collaboration on critical validation projects.

Requirements

  • Extensive experience in QV and/or CSV within the pharmaceutical or biotech industry
  • Bachelor’s degree in engineering, life sciences, computer science, or related field
  • Proven leadership experience managing validation teams and projects
  • Deep knowledge of regulatory requirements and qualification/validation lifecycle principles
  • Strong communication, stakeholder management, and problem-solving skills
  • Full proficiency in English and German
  • Collaborative and engaging leadership in fast-paced environments
  • Strong leadership, adaptability, and focus on team development

Tasks

  • Lead QA review and approval of qualification and validation documentation
  • Develop and implement validation strategies aligned with GMP and GAMP
  • Support audits, inspections, and investigations related to QV and CSV
  • Trend EM data and monitor room/utility conditions
  • Validate QC methods and cleaning processes
  • Collaborate with cross-functional teams on validation projects
  • Mentor team members and stakeholders to promote quality excellence

Work Experience

  • approx. 4 - 6 years

Education

  • Bachelor's degreeOR
  • Master's degree

Languages

  • EnglishBusiness Fluent
  • GermanBusiness Fluent
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