BeOne Medicines I GmbH
Associate Director, External Supply Quality Europe(m/w/x)
Full-timeWith HomeofficeManagement
Basel
New Job?Nejo!
The AI Job Search Engine
SO
SobiExternal Quality Operation Manager (EQOM)(m/w/x)
Basel
Full-timeWith Home OfficeSenior
Description
You will drive quality oversight of external partners, ensuring the reliable supply of medicines. By bridging the gap between the organization and manufacturers, you'll turn compliance into a competitive advantage.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
Requirements
- •Ability to thrive in dynamic environments
- •Proactive and flexible work approach
- •Ownership and quality perspective
- •Strong relationship building and influencing skills
- •Energy, structure, and continuous-improvement mindset
- •Motivation to help patients
- •University degree in relevant science area
- •Experience in pharmaceutical or biotech products
- •Experience in QA, production, GMP, or GDP
- •Experience managing quality oversight of CMOs
- •Curriculum for batch release qualification evaluation
- •Fluent spoken and written English
- •Experience in global operation environments
- •Experience leading Quality KPI assessments
- •Proven track record with Health Authorities
- •Understanding of risk management fundamentals
Education
Master's degree
Work Experience
5 years
Tasks
- •Act as the primary quality contact for contract manufacturing organizations
- •Ensure manufacturing and distribution comply with quality systems and regulations
- •Support product release by the Qualified Person delegate
- •Assist with the qualification of external service providers
- •Establish and maintain comprehensive Quality Technical Agreements
- •Implement quality risk assessments and monitor performance metrics
- •Define remediation plans to address quality issues
- •Drive process and product quality improvement initiatives
- •Assess product reviews and stability reports from partners
- •Manage and approve deviations, CAPAs, and complaints
- •Oversee change requests from both the company and partners
- •Support quality audits of external manufacturing sites
- •Lead the strategy for key quality transformation initiatives
- •Represent quality interests in tech transfers and product launches
- •Ensure partner readiness for health authority inspections
- •Support health authority audits of the company
- •Escalate critical quality issues to management and cross-functional teams
- •Maintain strong collaboration across global quality operations
Tools & Technologies
GMPGDPCMOsFDAEMEAQuality KPI assessmentRisk assessment tools
Languages
English – Business Fluent
Benefits
Flexible Working
- •Hybrid work model
Competitive Pay
- •Competitive compensation
Family Support
- •Work/life balance emphasis
Informal Culture
- •Collaborative team-oriented environment
Career Advancement
- •Professional growth opportunities
Other Benefits
- •Diversity and Inclusion
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Sobi 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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SO
SobiExternal Quality Operation Manager (EQOM)(m/w/x)
Basel
Full-timeWith Home OfficeSenior
New Job?Nejo!
The AI Job Search Engine
Description
You will drive quality oversight of external partners, ensuring the reliable supply of medicines. By bridging the gap between the organization and manufacturers, you'll turn compliance into a competitive advantage.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
Requirements
- •Ability to thrive in dynamic environments
- •Proactive and flexible work approach
- •Ownership and quality perspective
- •Strong relationship building and influencing skills
- •Energy, structure, and continuous-improvement mindset
- •Motivation to help patients
- •University degree in relevant science area
- •Experience in pharmaceutical or biotech products
- •Experience in QA, production, GMP, or GDP
- •Experience managing quality oversight of CMOs
- •Curriculum for batch release qualification evaluation
- •Fluent spoken and written English
- •Experience in global operation environments
- •Experience leading Quality KPI assessments
- •Proven track record with Health Authorities
- •Understanding of risk management fundamentals
Education
Master's degree
Work Experience
5 years
Tasks
- •Act as the primary quality contact for contract manufacturing organizations
- •Ensure manufacturing and distribution comply with quality systems and regulations
- •Support product release by the Qualified Person delegate
- •Assist with the qualification of external service providers
- •Establish and maintain comprehensive Quality Technical Agreements
- •Implement quality risk assessments and monitor performance metrics
- •Define remediation plans to address quality issues
- •Drive process and product quality improvement initiatives
- •Assess product reviews and stability reports from partners
- •Manage and approve deviations, CAPAs, and complaints
- •Oversee change requests from both the company and partners
- •Support quality audits of external manufacturing sites
- •Lead the strategy for key quality transformation initiatives
- •Represent quality interests in tech transfers and product launches
- •Ensure partner readiness for health authority inspections
- •Support health authority audits of the company
- •Escalate critical quality issues to management and cross-functional teams
- •Maintain strong collaboration across global quality operations
Tools & Technologies
GMPGDPCMOsFDAEMEAQuality KPI assessmentRisk assessment tools
Languages
English – Business Fluent
Benefits
Flexible Working
- •Hybrid work model
Competitive Pay
- •Competitive compensation
Family Support
- •Work/life balance emphasis
Informal Culture
- •Collaborative team-oriented environment
Career Advancement
- •Professional growth opportunities
Other Benefits
- •Diversity and Inclusion
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Sobi 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
Sobi
Industry
Pharmaceuticals
Description
The company is a specialized biopharmaceutical company dedicated to rare diseases and committed to developing innovative therapies.
Not a perfect match?
- BeOne Medicines I GmbH
Associate Director, External Supply Quality Europe(m/w/x)
Full-timeWith HomeofficeManagementBasel - Sobi
External Manufacturing Manager(m/w/x)
Full-timeWith HomeofficeSeniorBasel - Novartis
Site Quality Head(m/w/x)
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Senior MSAT Process Manager Small Molecules(m/w/x)
Full-timeWith HomeofficeSeniorBasel - Sobi
Senior Pharmacovigilance Agreements Manager(m/w/x)
Full-timeWith HomeofficeSeniorBasel