Novartis
Site Quality Head(m/w/x)
Vollzeitmit HomeofficeSenior
Basel
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
BEBeOne Medicines I GmbH
Associate Director, External Supply Quality Europe(m/w/x)
Basel
Vollzeitmit HomeofficeManagement
Nejo KI-Zusammenfassung
Leading Small Molecule commercial product quality team, overseeing European CMO performance management. 6+ years managerial experience and in-depth GMP in quality/manufacturing required. European travel expected.
Anforderungen
- 6+ years of managerial experience
- Ability to lead teams and manage staff
- Strong PC literacy; MS Office skills
- In-depth GMP experience in quality and manufacturing
- Ability to apply logical and scientific thinking
- Inspiring and encouraging team members
Aufgaben
- Lead the Small Molecule commercial product quality team
- Ensure compliance with regulatory requirements and BeOne standards
- Oversee BeOne qualified CMO performance management in Europe
- Evaluate trends and implement remediation as needed
- Act as the primary escalation point for CMO quality managers
- Review and approve change control strategies for CMO changes
- Manage APQR activities for CMO manufactured BeOne products
- Handle batch-related deviations and implement effective CAPAs at CMO
- Perform PIP (Person in Plant) activities
- Oversee inspection management for successful CMO and BeOne inspections
- Ensure quality processes meet Health Authorities' expectations
- Advise on Quality Agreement content and updates
- Collaborate cross-functionally with Manufacturing, Supply Chain, and Regulatory CMC
- Ensure timely batch release for commercial product supply
- Support product recalls from the commercial supply chain when necessary
- Author Standard Operating Procedures for the department
Berufserfahrung
- 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- MS Office
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens BeOne Medicines I GmbH 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.
Noch nicht perfekt?
- Revolution Medicines
Director, CMC Regulatory, Europe(m/w/x)
Vollzeitmit HomeofficeManagementBasel - Sobi
QA Analytical Specialist(m/w/x)
Vollzeitmit HomeofficeSeniorBasel - Revolution Medicines
Senior Director, Regulatory Affairs, Europe(m/w/x)
Vollzeitmit HomeofficeSeniorBasel - Revolution Medicines
Associate Director, People Operations, Europe(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenBasel
BEBeOne Medicines I GmbH
Associate Director, External Supply Quality Europe(m/w/x)
Basel
Vollzeitmit HomeofficeManagement
Nejo KI-Zusammenfassung
Leading Small Molecule commercial product quality team, overseeing European CMO performance management. 6+ years managerial experience and in-depth GMP in quality/manufacturing required. European travel expected.
Anforderungen
- 6+ years of managerial experience
- Ability to lead teams and manage staff
- Strong PC literacy; MS Office skills
- In-depth GMP experience in quality and manufacturing
- Ability to apply logical and scientific thinking
- Inspiring and encouraging team members
Aufgaben
- Lead the Small Molecule commercial product quality team
- Ensure compliance with regulatory requirements and BeOne standards
- Oversee BeOne qualified CMO performance management in Europe
- Evaluate trends and implement remediation as needed
- Act as the primary escalation point for CMO quality managers
- Review and approve change control strategies for CMO changes
- Manage APQR activities for CMO manufactured BeOne products
- Handle batch-related deviations and implement effective CAPAs at CMO
- Perform PIP (Person in Plant) activities
- Oversee inspection management for successful CMO and BeOne inspections
- Ensure quality processes meet Health Authorities' expectations
- Advise on Quality Agreement content and updates
- Collaborate cross-functionally with Manufacturing, Supply Chain, and Regulatory CMC
- Ensure timely batch release for commercial product supply
- Support product recalls from the commercial supply chain when necessary
- Author Standard Operating Procedures for the department
Berufserfahrung
- 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- MS Office
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens BeOne Medicines I GmbH 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 Medicines I GmbH
Branche
Pharmaceuticals
Beschreibung
The company is focused on fighting cancer and offers opportunities for scientific and business professionals.
Noch nicht perfekt?
- Novartis
Site Quality Head(m/w/x)
Vollzeitmit HomeofficeSeniorBasel - Revolution Medicines
Director, CMC Regulatory, Europe(m/w/x)
Vollzeitmit HomeofficeManagementBasel - Sobi
QA Analytical Specialist(m/w/x)
Vollzeitmit HomeofficeSeniorBasel - Revolution Medicines
Senior Director, Regulatory Affairs, Europe(m/w/x)
Vollzeitmit HomeofficeSeniorBasel - Revolution Medicines
Associate Director, People Operations, Europe(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenBasel