BeOne Medicines USA, Inc.
Associate Director, QMS Process Improvement and Analytics(m/w/x)
Vollzeitnur vor OrtSenior
Basel
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
BEBeOne Medicines I GmbH
Director, QMS BPO, Quality Issue Escalation, Risk & Knowledge(m/w/x)
Basel
ab CHF 178.600 - 223.300 / Jahr
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Managing global GxP and Quality incidents for a growing oncology pharmaceutical company. 6 years of leadership experience required. 4-day work week, personal mentoring program.
Anforderungen
- Bachelor’s degree and 8+ years in quality sciences, systems, or related fields in regulated industry
- Master’s degree and 10+ years direct experience preferred
- 6 years managerial or team/project/program leadership experience
- Strong PC literacy; MS Office skills; ability to learn specialized platforms
- Experience with regulatory interactions and health authority communication
Aufgaben
- Manage global GxP and Quality incidents
- Initiate GxP/Quality incident prevention measures
- Maintain and improve incident management processes
- Ensure compliance with regulatory requirements (e.g., ICH Q9)
- Serve as SME for quality risk assessment and investigations
- Facilitate change control and resolution of complex quality issues
- Review regulatory CMC submission content
- Build and grow knowledge management processes
- Collaborate with Product Data Quality team for rapid data access
- Develop and implement GxP/Quality incident management processes
- Oversee intake, triage, investigation, documentation, and resolution of incidents
- Partner with cross-functional teams for incident management
- Conduct comprehensive root cause investigations
- Develop and oversee CAPA plans and lessons learned
- Initiate and execute market actions when necessary
- Ensure regulatory and GxP compliance for escalation and notification
- Prepare for and support inspections and audits
- Develop and deliver training on incident management
- Share lessons learned from managed incidents
- Promote a culture of quality and accountability
- Track and report on key performance indicators
- Monitor and report incident trends
Berufserfahrung
- 8 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- MS Office
- Outlook
- Word
- Excel
- PowerPoint
- Veeva
- Power BI
- Calyx
- SAP
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?
- BeOne Medicines USA, Inc.
Associate Director, BPO Global APQR & Product Data Quality(m/w/x)
Vollzeitnur vor OrtSeniorBasel - BeOne
Director, Product Quality Lead(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Revolution Medicines
Executive Director, Head of Quality, Europe(m/w/x)
Vollzeitnur vor OrtSeniorBasel - BeOne Medicines USA, Inc.
Senior Manager, Digital Quality Management Systems, Business Analyst(m/w/x)
Vollzeitnur vor OrtManagementBasel
BEBeOne Medicines I GmbH
Director, QMS BPO, Quality Issue Escalation, Risk & Knowledge(m/w/x)
Basel
ab CHF 178.600 - 223.300 / Jahr
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Managing global GxP and Quality incidents for a growing oncology pharmaceutical company. 6 years of leadership experience required. 4-day work week, personal mentoring program.
Anforderungen
- Bachelor’s degree and 8+ years in quality sciences, systems, or related fields in regulated industry
- Master’s degree and 10+ years direct experience preferred
- 6 years managerial or team/project/program leadership experience
- Strong PC literacy; MS Office skills; ability to learn specialized platforms
- Experience with regulatory interactions and health authority communication
Aufgaben
- Manage global GxP and Quality incidents
- Initiate GxP/Quality incident prevention measures
- Maintain and improve incident management processes
- Ensure compliance with regulatory requirements (e.g., ICH Q9)
- Serve as SME for quality risk assessment and investigations
- Facilitate change control and resolution of complex quality issues
- Review regulatory CMC submission content
- Build and grow knowledge management processes
- Collaborate with Product Data Quality team for rapid data access
- Develop and implement GxP/Quality incident management processes
- Oversee intake, triage, investigation, documentation, and resolution of incidents
- Partner with cross-functional teams for incident management
- Conduct comprehensive root cause investigations
- Develop and oversee CAPA plans and lessons learned
- Initiate and execute market actions when necessary
- Ensure regulatory and GxP compliance for escalation and notification
- Prepare for and support inspections and audits
- Develop and deliver training on incident management
- Share lessons learned from managed incidents
- Promote a culture of quality and accountability
- Track and report on key performance indicators
- Monitor and report incident trends
Berufserfahrung
- 8 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- MS Office
- Outlook
- Word
- Excel
- PowerPoint
- Veeva
- Power BI
- Calyx
- SAP
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?
- BeOne Medicines USA, Inc.
Associate Director, QMS Process Improvement and Analytics(m/w/x)
Vollzeitnur vor OrtSeniorBasel - BeOne Medicines USA, Inc.
Associate Director, BPO Global APQR & Product Data Quality(m/w/x)
Vollzeitnur vor OrtSeniorBasel - BeOne
Director, Product Quality Lead(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Revolution Medicines
Executive Director, Head of Quality, Europe(m/w/x)
Vollzeitnur vor OrtSeniorBasel - BeOne Medicines USA, Inc.
Senior Manager, Digital Quality Management Systems, Business Analyst(m/w/x)
Vollzeitnur vor OrtManagementBasel