Lonza
(Senior) QA Expert Manufacturing Oversight(m/w/x)
Full-timeOn-siteExperienced
Stein (AR)
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CSCSL Vifor
Manager, CMO Quality EMEA(m/w/x)
Sankt Gallen
Full-timeOn-siteManagement
Nejo AI Summary
Quality oversight for outsourced production of iron deficiency and nephrology therapies. 5+ years GxP experience in pharma with thorough regulatory understanding required. Work in a global matrix organization.
Requirements
- Four-year degree in relevant business or science, or equivalent education and experience
- Minimum of 5 years’ experience in GxP environment in pharmaceutical industry
- Thorough understanding of required regulations including FDA, PiC/S, European regulation, Therapeutics Goods Authority, Canadian Health Authority
- Strong industry and quality system knowledge
- Comfortable working in a global, matrix organization
- Experience in CMO business highly preferred
- Strong organizational skills
- Fluency in English (written and spoken); German knowledge is a plus
Tasks
- Manage production efforts at Contract Manufacturing Organizations (CMOs)
- Provide quality oversight for outsourced operational activities
- Develop and enforce Quality Agreements
- Support CMO Changes and Deviations
- Resolve quality issues
- Review Quality Performance KPIs
- Establish collaborative relationships with CMO and CSL stakeholders
- Initiate and negotiate CMO Quality Agreements
- Oversee and report CMO quality performance
- Escalate quality issues to key stakeholders
- Maintain standardized Quality Oversight processes
- Represent QA in cross-functional project teams
- Provide on-site presence at CMOs as needed
- Manage intake of new CMO projects and initiatives
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CSL Vifor 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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CSCSL Vifor
Manager, CMO Quality EMEA(m/w/x)
Sankt Gallen
Full-timeOn-siteManagement
Nejo AI Summary
Quality oversight for outsourced production of iron deficiency and nephrology therapies. 5+ years GxP experience in pharma with thorough regulatory understanding required. Work in a global matrix organization.
Requirements
- Four-year degree in relevant business or science, or equivalent education and experience
- Minimum of 5 years’ experience in GxP environment in pharmaceutical industry
- Thorough understanding of required regulations including FDA, PiC/S, European regulation, Therapeutics Goods Authority, Canadian Health Authority
- Strong industry and quality system knowledge
- Comfortable working in a global, matrix organization
- Experience in CMO business highly preferred
- Strong organizational skills
- Fluency in English (written and spoken); German knowledge is a plus
Tasks
- Manage production efforts at Contract Manufacturing Organizations (CMOs)
- Provide quality oversight for outsourced operational activities
- Develop and enforce Quality Agreements
- Support CMO Changes and Deviations
- Resolve quality issues
- Review Quality Performance KPIs
- Establish collaborative relationships with CMO and CSL stakeholders
- Initiate and negotiate CMO Quality Agreements
- Oversee and report CMO quality performance
- Escalate quality issues to key stakeholders
- Maintain standardized Quality Oversight processes
- Represent QA in cross-functional project teams
- Provide on-site presence at CMOs as needed
- Manage intake of new CMO projects and initiatives
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CSL Vifor 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
CSL Vifor
Industry
Pharmaceuticals
Description
Das Unternehmen ist ein globaler Partner für pharmazeutische Produkte und innovative Therapien in der Eisenmangel- und Nephrologie.
Not a perfect match?
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