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BA
Bavarian Nordic Berna GmbH
3mo ago

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

Bern
Full-timeWith Home OfficeManagement

Description

In this role, you will lead a team to ensure that equipment and systems meet regulatory standards while collaborating with various departments to support the launch and transformation of manufacturing facilities.

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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

Education

Bachelor's degree
OR
Master's degree

Work Experience

approx. 4 - 6 years

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

Languages

English – Business Fluent

German – Business Fluent

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