Sobi
External Quality Operation Manager (EQOM)(m/w/x)
Full-timeWith HomeofficeSenior
Basel
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Acting as Qualified Person for site operations, overseeing quality governance across GxP functions in pharmaceutical production. 10-15 years in pharma/chemical industry with FDA/Swissmedic compliance experience required. Work in a global pharmaceutical setting.
Requirements
- 10–15 years of experience in the pharmaceutical or chemical industry
- University degree in Chemistry, Pharmacy, or related discipline
- Strong knowledge of regulatory requirements and cGMP standards
- Experience with FDA/Swissmedic regulations and compliance
- Dynamic, resilient, and versatile approach to problem-solving
- Demonstrated people leadership and team management skills
- Excellent communication skills and ability to collaborate across functions
- Fluency in German and English
Tasks
- Lead the Site Quality organization
- Foster a culture of compliance and continuous improvement
- Ensure adherence to cGMP and regulatory requirements
- Act as Qualified Person for site operations
- Oversee quality governance across all GxP functions
- Ensure robust risk management
- Approve or reject raw materials, facilities, utilities, and finished products
- Drive execution of training programs
- Maintain compliance with DI and eCompliance standards
- Manage internal and external audits and inspections
- Handle regulatory submissions
- Ensure effective complaint investigations
- Manage exception processes
Work Experience
- 10 - 15 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis 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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Acting as Qualified Person for site operations, overseeing quality governance across GxP functions in pharmaceutical production. 10-15 years in pharma/chemical industry with FDA/Swissmedic compliance experience required. Work in a global pharmaceutical setting.
Requirements
- 10–15 years of experience in the pharmaceutical or chemical industry
- University degree in Chemistry, Pharmacy, or related discipline
- Strong knowledge of regulatory requirements and cGMP standards
- Experience with FDA/Swissmedic regulations and compliance
- Dynamic, resilient, and versatile approach to problem-solving
- Demonstrated people leadership and team management skills
- Excellent communication skills and ability to collaborate across functions
- Fluency in German and English
Tasks
- Lead the Site Quality organization
- Foster a culture of compliance and continuous improvement
- Ensure adherence to cGMP and regulatory requirements
- Act as Qualified Person for site operations
- Oversee quality governance across all GxP functions
- Ensure robust risk management
- Approve or reject raw materials, facilities, utilities, and finished products
- Drive execution of training programs
- Maintain compliance with DI and eCompliance standards
- Manage internal and external audits and inspections
- Handle regulatory submissions
- Ensure effective complaint investigations
- Manage exception processes
Work Experience
- 10 - 15 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis 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
Novartis
Industry
Pharmaceuticals
Description
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Not a perfect match?
- Sobi
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Head of Main Department Technical Quality(m/w/x)
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Associate Director, External Supply Quality Europe(m/w/x)
Full-timeWith HomeofficeManagementBasel - Roche
Group Director - Safety Analytics and Reporting(m/w/x)
Full-timeWith HomeofficeManagementBasel - IQVIA
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