Lonza Cologne GmbH
Quality Site Head(m/w/x)
Full-timeOn-siteSenior
Köln
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MEMerck & Co., Inc., Rahway, NJ, USA
Quality Assurance Lead(m/w/x)
Köln
Full-timeOn-siteManagement
Nejo AI Summary
Leading a QA team of ten for sterile biopharmaceutical production. Master's in Biology/Biotech/Pharma, 10 years experience, 3 in QA leadership, and GMP inspection experience required. Hybrid work model, complex manufacturing site.
Requirements
- Masterabschluss in Biologie, Biotechnologie oder Pharmazie
- 10 Jahre Berufserfahrung, 3 Jahre QA-Leitung
- Erfahrung in steriler Produktion und Qualitätssicherung
- Erfahrung mit regulatorischen GMP-Inspektionen
- Verständnis internationaler GMP-Anforderungen
- Ausgeprägte Kommunikations- und Führungskompetenz
- Sehr gute Deutsch- und Englischkenntnisse
- Bereitschaft zur Arbeit in BSL-2/BSL-3-Bereichen
- Entscheidungsstärke, Compliance-Management und Eigenverantwortung
- Master’s degree in Biology, Biotechnology or Pharmacy
- 10 years experience, 3 years Quality leadership
- Experience in sterile manufacturing and Quality Assurance
- Track record with regulatory GMP inspections
- Understanding of international GMP regulations
- Excellent leadership and problem-solving skills
- Fluency in German and English
- Willingness to work in BSL-2/BSL-3 environments
- Decision-making, ambiguity management and pragmatic leadership
- No relocation
Tasks
- Lead and develop a QA team of ten employees
- Manage performance using KPIs and continuous improvement
- Collaborate with Manufacturing, QC, Engineering, and Supply
- Coach non-quality teams on GMP and quality mindset
- Oversee Quality Systems, Assurance, and Release
- Review and approve GMP documentation and SOPs
- Develop and execute the Site Quality Plan
- Coordinate Health Authority inspections and customer audits
- Plan and execute internal self-inspections
- Manage training systems and supplier quality
- Oversee quality agreements and Product Quality Reviews
- Ensure data integrity across all systems
- Qualify and coach cleanroom personnel
- Manage timely batch record reviews and releases
- Handle deviations, CAPAs, and change management
- Maintain the Site Master File and risk management
- Act as the SAP QM key user
- Manage artwork and prepare regulatory submission documents
- Facilitate the Site Quality Council and track KPIs
- Provide independent QA oversight for the Cologne site
- Lead the quality organization during the Quality Lead's absence
Work Experience
- 10 years
Education
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- GMP
- BSL-2
- BSL-3
Benefits
Flexible Working
- Flexible work arrangements
- Hybrid work model
Diverse Work
- Broad and varied role
Other Benefits
- Complex manufacturing site
- Influence on quality performance
Purpose-Driven Work
- Clear accountability
- Stable, science-driven organization
Career Advancement
- International quality network
Job Security
- Long-term perspective
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Merck & Co., Inc., Rahway, NJ, USA 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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MEMerck & Co., Inc., Rahway, NJ, USA
Quality Assurance Lead(m/w/x)
Köln
Full-timeOn-siteManagement
Nejo AI Summary
Leading a QA team of ten for sterile biopharmaceutical production. Master's in Biology/Biotech/Pharma, 10 years experience, 3 in QA leadership, and GMP inspection experience required. Hybrid work model, complex manufacturing site.
Requirements
- Masterabschluss in Biologie, Biotechnologie oder Pharmazie
- 10 Jahre Berufserfahrung, 3 Jahre QA-Leitung
- Erfahrung in steriler Produktion und Qualitätssicherung
- Erfahrung mit regulatorischen GMP-Inspektionen
- Verständnis internationaler GMP-Anforderungen
- Ausgeprägte Kommunikations- und Führungskompetenz
- Sehr gute Deutsch- und Englischkenntnisse
- Bereitschaft zur Arbeit in BSL-2/BSL-3-Bereichen
- Entscheidungsstärke, Compliance-Management und Eigenverantwortung
- Master’s degree in Biology, Biotechnology or Pharmacy
- 10 years experience, 3 years Quality leadership
- Experience in sterile manufacturing and Quality Assurance
- Track record with regulatory GMP inspections
- Understanding of international GMP regulations
- Excellent leadership and problem-solving skills
- Fluency in German and English
- Willingness to work in BSL-2/BSL-3 environments
- Decision-making, ambiguity management and pragmatic leadership
- No relocation
Tasks
- Lead and develop a QA team of ten employees
- Manage performance using KPIs and continuous improvement
- Collaborate with Manufacturing, QC, Engineering, and Supply
- Coach non-quality teams on GMP and quality mindset
- Oversee Quality Systems, Assurance, and Release
- Review and approve GMP documentation and SOPs
- Develop and execute the Site Quality Plan
- Coordinate Health Authority inspections and customer audits
- Plan and execute internal self-inspections
- Manage training systems and supplier quality
- Oversee quality agreements and Product Quality Reviews
- Ensure data integrity across all systems
- Qualify and coach cleanroom personnel
- Manage timely batch record reviews and releases
- Handle deviations, CAPAs, and change management
- Maintain the Site Master File and risk management
- Act as the SAP QM key user
- Manage artwork and prepare regulatory submission documents
- Facilitate the Site Quality Council and track KPIs
- Provide independent QA oversight for the Cologne site
- Lead the quality organization during the Quality Lead's absence
Work Experience
- 10 years
Education
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- GMP
- BSL-2
- BSL-3
Benefits
Flexible Working
- Flexible work arrangements
- Hybrid work model
Diverse Work
- Broad and varied role
Other Benefits
- Complex manufacturing site
- Influence on quality performance
Purpose-Driven Work
- Clear accountability
- Stable, science-driven organization
Career Advancement
- International quality network
Job Security
- Long-term perspective
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Merck & Co., Inc., Rahway, NJ, USA 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.
About the Company
Merck & Co., Inc., Rahway, NJ, USA
Industry
Pharmaceuticals
Description
Merck & Co., Inc. is a global biopharmaceutical company committed to discovering, developing, manufacturing, and marketing a broad range of innovative health care products.
Not a perfect match?
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