CHEPLAPHARM Arzneimittel GmbH
Global Head of Quality(m/w/x)
Vollzeitmit HomeofficeSenior
Greifswald, Berlin, Binningen
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
121201 F. Hoffmann-La Roche AG
Senior Quality Lead(m/w/x)
Basel
Vollzeitmit HomeofficeManagement
Nejo KI-Zusammenfassung
Designing and implementing QA strategies for global healthcare access. Strategic thinking and digital literacy required. Audit management from preparation to reporting.
Anforderungen
- Proactive, strategic thinking
- Thrives in collaborative, matrixed environment
- Passionate about driving Quality outcomes
- Strong digital and data literacy
- Comfortable asking challenging questions
- Extensive Quality Expertise
- Strong drug development process background
- Strong clinical trials background
- Robust cross-functional GCP experience
- Robust cross-functional GVP/PV experience
- Robust cross-functional Medical Devices/SaMD experience
- Proven track record leading Health Authority inspections
- Inspection readiness management
- Post-inspection management
- Advanced problem-solving skills
- Proactive, risk-based mindset
- Utilise data and data visualisation tools
- Exceptional relationship management skills
- Proven ability to negotiate effective solutions
- Proven ability to influence senior stakeholders
- Experience managing projects in global teams
- Experience managing projects in multicultural teams
- Passion for coaching others
- Passion for mentoring others
- Bachelor’s degree or equivalent in scientific field
- Bachelor’s degree or equivalent in quality-related field
- Advanced degree preferred
Aufgaben
- Design and implement QA strategies
- Partner with business stakeholders to define QA approach
- Assess risks and adapt strategies using CtQ framework
- Determine required audits and develop methodologies
- Manage end-to-end audit process from preparation to reporting
- Manage quality issues and track systematic findings
- Escalate significant risks to PDQ management
- Evaluate quality positions to drive compliance action plans
- Lead high-level risk presentations and strategic discussions
- Communicate with business stakeholders, Pharma, Legal, and Regulatory Affairs
- Lead preparation for Health Authority inspections
- Train staff for major regulatory inspections
- Present quality strategies and conclusions to inspectors
- Contribute to PDQ's long-term strategic direction
- Lead compliance projects
- Mentor and develop Quality Leads within the team
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- data visualisation tools
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens 1201 F. Hoffmann-La Roche AG 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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121201 F. Hoffmann-La Roche AG
Senior Quality Lead(m/w/x)
Basel
Vollzeitmit HomeofficeManagement
Nejo KI-Zusammenfassung
Designing and implementing QA strategies for global healthcare access. Strategic thinking and digital literacy required. Audit management from preparation to reporting.
Anforderungen
- Proactive, strategic thinking
- Thrives in collaborative, matrixed environment
- Passionate about driving Quality outcomes
- Strong digital and data literacy
- Comfortable asking challenging questions
- Extensive Quality Expertise
- Strong drug development process background
- Strong clinical trials background
- Robust cross-functional GCP experience
- Robust cross-functional GVP/PV experience
- Robust cross-functional Medical Devices/SaMD experience
- Proven track record leading Health Authority inspections
- Inspection readiness management
- Post-inspection management
- Advanced problem-solving skills
- Proactive, risk-based mindset
- Utilise data and data visualisation tools
- Exceptional relationship management skills
- Proven ability to negotiate effective solutions
- Proven ability to influence senior stakeholders
- Experience managing projects in global teams
- Experience managing projects in multicultural teams
- Passion for coaching others
- Passion for mentoring others
- Bachelor’s degree or equivalent in scientific field
- Bachelor’s degree or equivalent in quality-related field
- Advanced degree preferred
Aufgaben
- Design and implement QA strategies
- Partner with business stakeholders to define QA approach
- Assess risks and adapt strategies using CtQ framework
- Determine required audits and develop methodologies
- Manage end-to-end audit process from preparation to reporting
- Manage quality issues and track systematic findings
- Escalate significant risks to PDQ management
- Evaluate quality positions to drive compliance action plans
- Lead high-level risk presentations and strategic discussions
- Communicate with business stakeholders, Pharma, Legal, and Regulatory Affairs
- Lead preparation for Health Authority inspections
- Train staff for major regulatory inspections
- Present quality strategies and conclusions to inspectors
- Contribute to PDQ's long-term strategic direction
- Lead compliance projects
- Mentor and develop Quality Leads within the team
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- data visualisation tools
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens 1201 F. Hoffmann-La Roche AG 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
1201 F. Hoffmann-La Roche AG
Branche
Pharmaceuticals
Beschreibung
Roche is dedicated to advancing science and ensuring access to healthcare for everyone, with over 100,000 employees globally.
Noch nicht perfekt?
- CHEPLAPHARM Arzneimittel GmbH
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