Sobi
External Manufacturing Manager(m/w/x)
Full-timeWith HomeofficeSenior
Basel
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SOSobi
External Quality Operation Manager (EQOM)(m/w/x)
Basel
Full-timeWith Home OfficeSenior
Nejo AI Summary
Primary quality contact for contract manufacturing organizations in rare disease biopharma, ensuring regulatory compliance. Strong relationship building and influencing skills essential. Hybrid work model.
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
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
Work Experience
- 5 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- GMP
- GDP
- CMOs
- FDA
- EMEA
- Quality KPI assessment
- Risk assessment tools
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.
Not a perfect match?
- BeOne Medicines I GmbH
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Head of Main Department Technical Quality(m/w/x)
Full-timeWith HomeofficeSeniorReinach - Sobi
Senior Pharmacovigilance Agreements Manager(m/w/x)
Full-timeWith HomeofficeSeniorBasel
SOSobi
External Quality Operation Manager (EQOM)(m/w/x)
Basel
Full-timeWith Home OfficeSenior
Nejo AI Summary
Primary quality contact for contract manufacturing organizations in rare disease biopharma, ensuring regulatory compliance. Strong relationship building and influencing skills essential. Hybrid work model.
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
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
Work Experience
- 5 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- GMP
- GDP
- CMOs
- FDA
- EMEA
- Quality KPI assessment
- Risk assessment tools
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?
- Sobi
External Manufacturing Manager(m/w/x)
Full-timeWith HomeofficeSeniorBasel - BeOne Medicines I GmbH
Associate Director, External Supply Quality Europe(m/w/x)
Full-timeWith HomeofficeManagementBasel - Novartis
Site Quality Head(m/w/x)
Full-timeWith HomeofficeSeniorBasel - Endress+Hauser
Head of Main Department Technical Quality(m/w/x)
Full-timeWith HomeofficeSeniorReinach - Sobi
Senior Pharmacovigilance Agreements Manager(m/w/x)
Full-timeWith HomeofficeSeniorBasel