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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
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Senior Quality Manager(m/w/x)
Full-timeOn-siteSeniorKöln
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
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.
Not a perfect match?
- Merck & Co., Inc., Rahway, NJ, USA
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