BeOne Medicines USA, Inc.
Associate Director, BPO Global APQR & Product Data Quality(m/w/x)
Vollzeitnur vor OrtSenior
Basel
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BEBeOne
Director, Product Quality Lead(m/w/x)
Basel
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Quality leadership for molecule-level governance and regulatory CMC submissions in cancer drug development. Master's degree with 10+ years experience preferred. Direct impact on life-saving cancer therapies.
Anforderungen
- Bachelor’s degree and 8+ years experience
- Master’s degree and 10+ years experience preferred
- 5+ years managerial or leadership experience
- Strong PC literacy and MS Office skills
- Experience in statistical modeling software
- Advanced degree in relevant field
- Extensive experience leading quality investigations
- Expertise in quality systems and regulations
- Strong leadership and problem-solving skills
- Experience developing global training programs
- Proficiency in quality tools and methodologies
- Effective communication across business functions
- Willingness to travel up to 20%
Aufgaben
- Represent the quality organization in molecule-level governance meetings
- Facilitate quality risk assessments and complex investigations
- Review regulatory CMC submission content for accuracy
- Manage product quality network teams for clinical and commercial programs
- Embed quality considerations into new product development and lifecycles
- Advise on CMC strategies and quality risk management for commercialization
- Monitor product quality performance to identify and drive improvements
- Lead cross-functional teams to enhance global quality systems
- Implement Quality Risk Management frameworks following ICH Q9 standards
- Support regulatory inspections and audits against global standards
- Mentor team members to develop product quality and leadership skills
- Analyze emerging scientific trends and their impact on products
Berufserfahrung
- 8 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- MS Office
- Outlook
- Word
- Excel
- PowerPoint
- Mintab
- JMP
- Tableau
- SciLab
- Lean
- Six Sigma
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens BeOne 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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BEBeOne
Director, Product Quality Lead(m/w/x)
Basel
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Quality leadership for molecule-level governance and regulatory CMC submissions in cancer drug development. Master's degree with 10+ years experience preferred. Direct impact on life-saving cancer therapies.
Anforderungen
- Bachelor’s degree and 8+ years experience
- Master’s degree and 10+ years experience preferred
- 5+ years managerial or leadership experience
- Strong PC literacy and MS Office skills
- Experience in statistical modeling software
- Advanced degree in relevant field
- Extensive experience leading quality investigations
- Expertise in quality systems and regulations
- Strong leadership and problem-solving skills
- Experience developing global training programs
- Proficiency in quality tools and methodologies
- Effective communication across business functions
- Willingness to travel up to 20%
Aufgaben
- Represent the quality organization in molecule-level governance meetings
- Facilitate quality risk assessments and complex investigations
- Review regulatory CMC submission content for accuracy
- Manage product quality network teams for clinical and commercial programs
- Embed quality considerations into new product development and lifecycles
- Advise on CMC strategies and quality risk management for commercialization
- Monitor product quality performance to identify and drive improvements
- Lead cross-functional teams to enhance global quality systems
- Implement Quality Risk Management frameworks following ICH Q9 standards
- Support regulatory inspections and audits against global standards
- Mentor team members to develop product quality and leadership skills
- Analyze emerging scientific trends and their impact on products
Berufserfahrung
- 8 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- MS Office
- Outlook
- Word
- Excel
- PowerPoint
- Mintab
- JMP
- Tableau
- SciLab
- Lean
- Six Sigma
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens BeOne 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.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
BeOne
Branche
Pharmaceuticals
Beschreibung
BeOne is growing rapidly and seeks scientific and business professionals passionate about fighting cancer.
Noch nicht perfekt?
- BeOne Medicines USA, Inc.
Associate Director, BPO Global APQR & Product Data Quality(m/w/x)
Vollzeitnur vor OrtSeniorBasel - BeOne Medicines USA, Inc.
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Vollzeitnur vor OrtSeniorBasel - 1201 F. Hoffmann-La Roche AG
Principal DP (Drug Product) Product Steward - Global MSAT(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Revolution Medicines
Executive Director, Head of Quality, Europe(m/w/x)
Vollzeitnur vor OrtSeniorBasel - 1201 F. Hoffmann-La Roche AG
Affiliate Network Regional Quality Lead(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBasel