F. Hoffmann-La Roche AG
.Global Fleet Program Owner(m/w/x)
Full-timeOn-siteSenior
Basel
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F.F. Hoffmann-La Roche AG
Drug Product (DP) Fleet Lead(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
Global strategy and systems ownership for drug product fleet in pharmaceutical manufacturing. 15+ years in pharma/biotech with GMP and PQS expertise required. Leading health authority interactions and pre-approval inspections.
Requirements
- Strong track record leading change management in regulated environments with cross-site impact
- Master’s degree in Engineering, Life Sciences, or related technical field; PhD preferred
- Minimum 15 years experience in pharmaceutical/biotech industry, Drug Product manufacturing, multi-site operations
- Strong understanding of GMP, Quality Systems (PQS), ICH Q10, ICH Q12
- Demonstrated expertise managing lifecycle of complex DP manufacturing equipment
- Proven ability to drive alignment and decision-making across diverse groups and locations
Tasks
- Define and drive global strategy for Drug Product Fleet
- Own and maintain DP fleet systems and standards
- Present global operating budget for DP fleet
- Lead health authority interactions and Pre-Approval Inspections
- Ensure DP equipment meets global specifications
- Maintain DP lifecycle deliverables and documentation
- Analyze proposed changes for DP fleet equivalency
- Conduct comparative analyses of GMP-critical aspects
- Monitor DP fleet performance and critical parameters
- Assess and manage network-wide impact of unplanned events
Work Experience
- 15 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- GMP
- Quality Systems (PQS)
- ICH Q10
- ICH Q12
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of F. Hoffmann-La Roche 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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F.F. Hoffmann-La Roche AG
Drug Product (DP) Fleet Lead(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
Global strategy and systems ownership for drug product fleet in pharmaceutical manufacturing. 15+ years in pharma/biotech with GMP and PQS expertise required. Leading health authority interactions and pre-approval inspections.
Requirements
- Strong track record leading change management in regulated environments with cross-site impact
- Master’s degree in Engineering, Life Sciences, or related technical field; PhD preferred
- Minimum 15 years experience in pharmaceutical/biotech industry, Drug Product manufacturing, multi-site operations
- Strong understanding of GMP, Quality Systems (PQS), ICH Q10, ICH Q12
- Demonstrated expertise managing lifecycle of complex DP manufacturing equipment
- Proven ability to drive alignment and decision-making across diverse groups and locations
Tasks
- Define and drive global strategy for Drug Product Fleet
- Own and maintain DP fleet systems and standards
- Present global operating budget for DP fleet
- Lead health authority interactions and Pre-Approval Inspections
- Ensure DP equipment meets global specifications
- Maintain DP lifecycle deliverables and documentation
- Analyze proposed changes for DP fleet equivalency
- Conduct comparative analyses of GMP-critical aspects
- Monitor DP fleet performance and critical parameters
- Assess and manage network-wide impact of unplanned events
Work Experience
- 15 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- GMP
- Quality Systems (PQS)
- ICH Q10
- ICH Q12
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of F. Hoffmann-La Roche 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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
F. Hoffmann-La Roche AG
Industry
Healthcare
Description
Das Unternehmen ist ein führender Anbieter von pharmazeutischen Wirkstoffen und setzt sich für die Gesundheitsversorgung weltweit ein.
Not a perfect match?
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