Dein persönlicher KI-Karriere-Agent
Senior Director - Quality Excellence(m/w/x)
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
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Senior Director - Quality Excellence(m/w/x)
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
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
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
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Director, Site Quality Head Drug Product(m/w/x)
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