Lonza
Director, Site Quality Head Drug Product(m/w/x)
Full-timeOn-siteManagement
Basel
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LOLonza Sales AG
Senior Director - Quality Excellence(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- Microsoft Office Suite
- Excel
- Word
- PowerPoint
- data analysis tools
- PMP Certification
- ICH Q8
- ICH Q9
- ICH Q10
- FDA
- EMA
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Lonza Sales AG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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LOLonza Sales AG
Senior Director - Quality Excellence(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- Microsoft Office Suite
- Excel
- Word
- PowerPoint
- data analysis tools
- PMP Certification
- ICH Q8
- ICH Q9
- ICH Q10
- FDA
- EMA
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Lonza Sales AG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Lonza Sales AG
Industry
Pharmaceuticals
Description
Lonza is a global leader in life sciences, providing innovative solutions that improve lives worldwide.
Not a perfect match?
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