BeOne Medicines I GmbH
Associate Director, External Supply Quality Europe(m/w/x)
Vollzeitmit HomeofficeManagement
Basel
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SOSobi
External Quality Operation Manager (EQOM)(m/w/x)
Basel
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Primary quality contact for contract manufacturing organizations in rare disease biopharma, ensuring regulatory compliance. Strong relationship building and influencing skills essential. Hybrid work model.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 5 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- GMP
- GDP
- CMOs
- FDA
- EMEA
- Quality KPI assessment
- Risk assessment tools
Benefits
Flexibles Arbeiten
- Hybrid work model
Attraktive Vergütung
- Competitive compensation
Familienfreundlichkeit
- Work/life balance emphasis
Lockere Unternehmenskultur
- Collaborative team-oriented environment
Karriere- und Weiterentwicklung
- Professional growth opportunities
Sonstige Vorteile
- Diversity and Inclusion
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Sobi erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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SOSobi
External Quality Operation Manager (EQOM)(m/w/x)
Basel
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Primary quality contact for contract manufacturing organizations in rare disease biopharma, ensuring regulatory compliance. Strong relationship building and influencing skills essential. Hybrid work model.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 5 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- GMP
- GDP
- CMOs
- FDA
- EMEA
- Quality KPI assessment
- Risk assessment tools
Benefits
Flexibles Arbeiten
- Hybrid work model
Attraktive Vergütung
- Competitive compensation
Familienfreundlichkeit
- Work/life balance emphasis
Lockere Unternehmenskultur
- Collaborative team-oriented environment
Karriere- und Weiterentwicklung
- Professional growth opportunities
Sonstige Vorteile
- Diversity and Inclusion
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Sobi erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
Sobi
Branche
Pharmaceuticals
Beschreibung
The company is a specialized biopharmaceutical company dedicated to rare diseases and committed to developing innovative therapies.
Noch nicht perfekt?
- BeOne Medicines I GmbH
Associate Director, External Supply Quality Europe(m/w/x)
Vollzeitmit HomeofficeManagementBasel - Sobi
External Manufacturing Manager(m/w/x)
Vollzeitmit HomeofficeSeniorBasel - Novartis
Site Quality Head(m/w/x)
Vollzeitmit HomeofficeSeniorBasel - Sobi
Senior Pharmacovigilance Agreements Manager(m/w/x)
Vollzeitmit HomeofficeSeniorBasel - Endress+Hauser
Head of Main Department Technical Quality(m/w/x)
Vollzeitmit HomeofficeSeniorReinach