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Senior QA Manager, QV & CSV(m/w/x)
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
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- HirslandenVollzeitmit HomeofficeSeniorBern
- Bavarian Nordic GmbH
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Senior QA Manager, QV & CSV(m/w/x)
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Über das Unternehmen
Bavarian Nordic Berna GmbH
Branche
Pharmaceuticals
Beschreibung
The company is a global leader in developing life-saving vaccines with over 30 years of experience.
Noch nicht perfekt?
- Hirslanden
Leitung Qualitätsmanagement(m/w/x)
Vollzeitmit HomeofficeSeniorBern - Bavarian Nordic GmbH
Demand and Supply Planner(m/w/x)
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Head of Commercial Technology and Innovation(m/w/x)
Vollzeitmit HomeofficeManagementBern - Consulteer
Test Manager(m/w/x)
Vollzeitmit HomeofficeManagementBern - Finanzverwaltung des Kantons Bern
Fachbereichsleiter SAP Supportprozesse und Qualitätssicherung(m/w/x)
Vollzeitmit HomeofficeManagementBern