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Commissioning & Qualification Regional Lead(m/w/x)
Developing C&Q strategy for global pharmaceutical projects, ensuring alignment with ISO standards. Strategic systems thinking and executive presence required. Overseeing project cost estimates and C&Q schedules.
Requirements
- Strategic systems thinking
- Strong drive for execution
- Compliance-focused mindset
- Exceptional executive presence
- Ability to navigate complex organizational dynamics
- Influencing senior partners and stakeholders
- Passion for innovation and collaboration
- Building organizational capability
- Motivating diverse technical teams
- University Degree in Engineering, Science, or related discipline
- At least 10 years experience in biopharmaceutical industry
- Vast experience in Commissioning, Qualification, and Validation (CQV)
- Experience with sterile manufacturing, utilities, facilities, and automation systems
- In-depth knowledge of global regulations (FDA, EMA, ICH)
- Application of industry best practices within GMP environment
- Proven track record leading regional functions
- Managing portfolio of large-scale capital projects
- Strong business and financial acumen
- Experience in contract negotiations
- Managing strategic service provider relationships
- Ability to drive change and standardize processes
- Implementation of systems like eVal Roche
- Flexibility and willingness to travel approximately 20% - 30%
- Potential short-term assignments at project sites
Tasks
- Oversee C&Q strategy development
- Ensure alignment with global standards
- Integrate lessons learned
- Review project cost estimates
- Establish robust C&Q schedules
- Mitigate business risk
- Drive internal resource planning
- Collaborate on long-term staff development
- Organize C&Q workshops
- Integrate new knowledge
- Feed improvements into global processes
- Ensure robust monthly reporting
- Track project status
- Identify and escalate project risks
- Perform C&Q peer reviews
- Evaluate project status
- Ensure compliance across equipment lifecycle
- Monitor global industry trends
- Implement innovative qualification processes
- Drive sustainable and cost-effective practices
Work Experience
- 10 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- eVal Roche
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Commissioning & Qualification Regional Lead(m/w/x)
Developing C&Q strategy for global pharmaceutical projects, ensuring alignment with ISO standards. Strategic systems thinking and executive presence required. Overseeing project cost estimates and C&Q schedules.
Requirements
- Strategic systems thinking
- Strong drive for execution
- Compliance-focused mindset
- Exceptional executive presence
- Ability to navigate complex organizational dynamics
- Influencing senior partners and stakeholders
- Passion for innovation and collaboration
- Building organizational capability
- Motivating diverse technical teams
- University Degree in Engineering, Science, or related discipline
- At least 10 years experience in biopharmaceutical industry
- Vast experience in Commissioning, Qualification, and Validation (CQV)
- Experience with sterile manufacturing, utilities, facilities, and automation systems
- In-depth knowledge of global regulations (FDA, EMA, ICH)
- Application of industry best practices within GMP environment
- Proven track record leading regional functions
- Managing portfolio of large-scale capital projects
- Strong business and financial acumen
- Experience in contract negotiations
- Managing strategic service provider relationships
- Ability to drive change and standardize processes
- Implementation of systems like eVal Roche
- Flexibility and willingness to travel approximately 20% - 30%
- Potential short-term assignments at project sites
Tasks
- Oversee C&Q strategy development
- Ensure alignment with global standards
- Integrate lessons learned
- Review project cost estimates
- Establish robust C&Q schedules
- Mitigate business risk
- Drive internal resource planning
- Collaborate on long-term staff development
- Organize C&Q workshops
- Integrate new knowledge
- Feed improvements into global processes
- Ensure robust monthly reporting
- Track project status
- Identify and escalate project risks
- Perform C&Q peer reviews
- Evaluate project status
- Ensure compliance across equipment lifecycle
- Monitor global industry trends
- Implement innovative qualification processes
- Drive sustainable and cost-effective practices
Work Experience
- 10 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- eVal Roche
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
F. Hoffmann-La Roche AG
Industry
Pharmaceuticals
Description
Das Unternehmen ist ein führender Anbieter von pharmazeutischen Wirkstoffen und setzt sich für die Gesundheitsversorgung weltweit ein.
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