Merck & Co., Inc., Rahway, NJ, USA
Quality Assurance Lead(m/w/x)
Full-timeOn-siteManagement
Köln
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Overseeing GxP/ISO compliance for non-viral gene transfer products at a life sciences company. Extensive QA leadership, GMP manufacturing, and lean principles implementation experience required. On-site leadership role.
Requirements
- Master’s degree or equivalent experience
- Extensive leadership in Quality Assurance
- Experience in GMP-regulated manufacturing
- Implementation of lean manufacturing principles
- Success leading high-performing teams
- Strategic planning and budget management
- Culture of empowerment and accountability
- Business proficiency in English and German
Tasks
- Lead the site's Quality Assurance and Quality Control functions
- Develop and execute the site’s Quality strategy
- Align Quality goals with global business objectives
- Drive continuous improvement and cost control initiatives
- Oversee compliance with GxP and ISO standards
- Monitor critical metrics at site and global levels
- Lead all customer and regulatory audits and inspections
- Manage corrective and preventive action programs
- Implement training plans to strengthen the Quality organization
- Represent the company to customers and regulatory authorities
Work Experience
- approx. 4 - 6 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- GMP
- Lean manufacturing
Benefits
Informal Culture
- Inclusive work environment
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Lonza Cologne GmbH 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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Overseeing GxP/ISO compliance for non-viral gene transfer products at a life sciences company. Extensive QA leadership, GMP manufacturing, and lean principles implementation experience required. On-site leadership role.
Requirements
- Master’s degree or equivalent experience
- Extensive leadership in Quality Assurance
- Experience in GMP-regulated manufacturing
- Implementation of lean manufacturing principles
- Success leading high-performing teams
- Strategic planning and budget management
- Culture of empowerment and accountability
- Business proficiency in English and German
Tasks
- Lead the site's Quality Assurance and Quality Control functions
- Develop and execute the site’s Quality strategy
- Align Quality goals with global business objectives
- Drive continuous improvement and cost control initiatives
- Oversee compliance with GxP and ISO standards
- Monitor critical metrics at site and global levels
- Lead all customer and regulatory audits and inspections
- Manage corrective and preventive action programs
- Implement training plans to strengthen the Quality organization
- Represent the company to customers and regulatory authorities
Work Experience
- approx. 4 - 6 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- GMP
- Lean manufacturing
Benefits
Informal Culture
- Inclusive work environment
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Lonza Cologne GmbH 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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Lonza Cologne GmbH
Industry
Pharmaceuticals
Description
Das Unternehmen ist ein weltweit führendes Unternehmen im Bereich Life Sciences und entwickelt nicht-virale Gentransferprodukte.
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