Roche
Head of Compliance and Quality Governance(m/w/x)
Vollzeitnur vor OrtSenior
Kaiseraugst
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
LOLonza Sales AG
Senior Director - Quality Excellence(m/w/x)
Basel
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Global Quality Compliance leadership for life sciences, preparing and governing the Lonza Quality Plan. Strong Quality and Compliance experience required. Facilitate Global Quality Councils, cross-functional teams.
Anforderungen
- Strong leadership and team management skills
- Excellent project management skills
- Excellent Quality and Compliance experience
- Strong analytical and problem-solving abilities
- High attention to detail and organizational skills
- Superior communication and interpersonal skills
- Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint) and data analysis tools
- BSc or Masters degree in life science
- PMP Certification ICH Q8,9,10 Proficiency preferred
- Demonstrated success in managing large-scale, complex programs
- Experience in developing and implementing risk management frameworks
- Multisite leadership and Growth Projects experience
- Successful track record with Health Authorities inspections (FDA, EMA, etc.)
- Experience in managing complex multi-functional teams in a multinational business environment
- Experience in working in a multi-cultural and multi-national environment
- Able to work in a matrix-team structure
- Strong and proven leadership capabilities
Aufgaben
- Lead global Quality Compliance programs and projects
- Prepare and govern Lonza Quality Plan
- Manage Compliance and Risk Management planning and reporting
- Facilitate Compliance, cross-functional, and Global Quality Councils
- Serve as ambassador for Compliance and Quality Excellence
- Provide guidance and support to managers across platforms and functions
- Develop and facilitate strategic monthly leadership team meetings
- Support global Quality Councils, including action tracking and minutes
- Oversee Compliance programs from initiation to completion
- Monitor program and project progress for timely delivery and quality outcomes
- Establish and maintain project management standards
- Operate as SME/SPOC for competency areas
- Support sites and platforms during regulatory inspections and investigations
- Manage complex escalations and address Executive leadership needs
- Ensure operational execution of strategic initiatives in Compliance and QMS
- Lead change management in operational planning
- Develop, monitor, and report on Lonza Quality Plan
- Drive global improvements and proactive risk mitigation
- Prepare and present detailed reports on Quality program performance
- Manage business reporting processes (weekly huddles, monthly Quality reports, etc.)
- Develop and monitor Quality KPI and KQI targets
- Build strong relationships with Global Quality, Regulatory Affairs, Operations, Finance, and platform/site leadership
- Use indirect leadership to drive decision-making and alignment
- Facilitate executive-level discussions
- Influence stakeholders to focus on long-term Quality Excellence goals
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- Microsoft Office Suite
- Excel
- Word
- PowerPoint
- data analysis tools
- PMP Certification
- ICH Q8
- ICH Q9
- ICH Q10
- FDA
- EMA
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Lonza Sales 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.
Noch nicht perfekt?
- BeOne Medicines USA, Inc.
Associate Director, QMS Process Improvement and Analytics(m/w/x)
Vollzeitnur vor OrtSeniorBasel - BeOne
Director, Product Quality Lead(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Lonza
Director, Site Quality Head Drug Product(m/w/x)
Vollzeitnur vor OrtManagementBasel - BeOne Medicines I GmbH
Regional Clinical Compliance Director/ Senior Director(m/w/x)
Vollzeitnur vor OrtManagementBasel
LOLonza Sales AG
Senior Director - Quality Excellence(m/w/x)
Basel
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Global Quality Compliance leadership for life sciences, preparing and governing the Lonza Quality Plan. Strong Quality and Compliance experience required. Facilitate Global Quality Councils, cross-functional teams.
Anforderungen
- Strong leadership and team management skills
- Excellent project management skills
- Excellent Quality and Compliance experience
- Strong analytical and problem-solving abilities
- High attention to detail and organizational skills
- Superior communication and interpersonal skills
- Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint) and data analysis tools
- BSc or Masters degree in life science
- PMP Certification ICH Q8,9,10 Proficiency preferred
- Demonstrated success in managing large-scale, complex programs
- Experience in developing and implementing risk management frameworks
- Multisite leadership and Growth Projects experience
- Successful track record with Health Authorities inspections (FDA, EMA, etc.)
- Experience in managing complex multi-functional teams in a multinational business environment
- Experience in working in a multi-cultural and multi-national environment
- Able to work in a matrix-team structure
- Strong and proven leadership capabilities
Aufgaben
- Lead global Quality Compliance programs and projects
- Prepare and govern Lonza Quality Plan
- Manage Compliance and Risk Management planning and reporting
- Facilitate Compliance, cross-functional, and Global Quality Councils
- Serve as ambassador for Compliance and Quality Excellence
- Provide guidance and support to managers across platforms and functions
- Develop and facilitate strategic monthly leadership team meetings
- Support global Quality Councils, including action tracking and minutes
- Oversee Compliance programs from initiation to completion
- Monitor program and project progress for timely delivery and quality outcomes
- Establish and maintain project management standards
- Operate as SME/SPOC for competency areas
- Support sites and platforms during regulatory inspections and investigations
- Manage complex escalations and address Executive leadership needs
- Ensure operational execution of strategic initiatives in Compliance and QMS
- Lead change management in operational planning
- Develop, monitor, and report on Lonza Quality Plan
- Drive global improvements and proactive risk mitigation
- Prepare and present detailed reports on Quality program performance
- Manage business reporting processes (weekly huddles, monthly Quality reports, etc.)
- Develop and monitor Quality KPI and KQI targets
- Build strong relationships with Global Quality, Regulatory Affairs, Operations, Finance, and platform/site leadership
- Use indirect leadership to drive decision-making and alignment
- Facilitate executive-level discussions
- Influence stakeholders to focus on long-term Quality Excellence goals
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- Microsoft Office Suite
- Excel
- Word
- PowerPoint
- data analysis tools
- PMP Certification
- ICH Q8
- ICH Q9
- ICH Q10
- FDA
- EMA
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Lonza Sales 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.
Über das Unternehmen
Lonza Sales AG
Branche
Pharmaceuticals
Beschreibung
Lonza is a global leader in life sciences, providing innovative solutions that improve lives worldwide.
Noch nicht perfekt?
- Roche
Head of Compliance and Quality Governance(m/w/x)
Vollzeitnur vor OrtSeniorKaiseraugst - BeOne Medicines USA, Inc.
Associate Director, QMS Process Improvement and Analytics(m/w/x)
Vollzeitnur vor OrtSeniorBasel - BeOne
Director, Product Quality Lead(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Lonza
Director, Site Quality Head Drug Product(m/w/x)
Vollzeitnur vor OrtManagementBasel - BeOne Medicines I GmbH
Regional Clinical Compliance Director/ Senior Director(m/w/x)
Vollzeitnur vor OrtManagementBasel