Roche
Head of Technology Strategy and Standards(m/w/x)
Vollzeitnur vor OrtManagement
Basel
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F.F. Hoffmann-La Roche AG
.Global Fleet Program Owner(m/w/x)
Basel
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Global fleet program ownership for DS and DP equipment standards. Strategic leadership and standardization champion required. Oversight for fleet concept implementation and technical change governance.
Anforderungen
- Strategic leadership and standardization champion
- Ability to drive alignment across diverse groups
- Excellent communication skills
- Decisive accountability for manufacturing systems
- High degree of technical integrity
- Precision in managing complex changes
- Ensuring global equivalency in regulated environment
- Master’s degree in Engineering, Life Sciences, or related technical field
- PhD is a plus
- Minimum 10 years pharmaceutical/biotech experience
- Focus on multi-site operations and system standardization
- Deep expertise in managing complex equipment lifecycle
- Strong understanding of GMP
- Strong understanding of Quality Systems (PQS)
- Strong understanding of global regulatory requirements (ICH Q10, ICH Q12)
- Proven track record in leading change management
- Performing cross-site impact assessments in GMP environment
- Exceptional leadership skills
- Ability to influence decision-making
- Drive results across engineering, quality, site leadership
Aufgaben
- Champion the 'design one, build many' philosophy
- Provide strategic and operational oversight for fleet concept implementation
- Act as single point of accountability for DS and DP fleet equipment standards
- Establish and maintain robust governance for technical changes
- Approve comparative analyses of GMP-critical and process-critical systems
- Serve as primary contact for health authority interactions
- Manage master inventory and status of fleet equipment
- Own global lifecycle deliverables including validation plans, SOPs, and URS
- Lead impact analysis for changes to ensure consistent implementation
- Decide on new technical requirements and deployment timelines
Berufserfahrung
- 10 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- GMP
- Quality Systems (PQS)
- ICH Q10
- ICH Q12
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens F. Hoffmann-La Roche 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?
- F. Hoffmann-La Roche AG
Quality Engineering Expert(m/w/x)
Vollzeitnur vor OrtSeniorBasel - F. Hoffmann-La Roche AG
Global MSAT Drug Substance Technology Deployment Steward(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Roche
Global MSAT Technology Deployment Group Lead(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Roche
Digital Quality Strategy Delivery Lead - Pharma Technical Operations(m/w/x)
Vollzeitnur vor OrtManagementBasel
F.F. Hoffmann-La Roche AG
.Global Fleet Program Owner(m/w/x)
Basel
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Global fleet program ownership for DS and DP equipment standards. Strategic leadership and standardization champion required. Oversight for fleet concept implementation and technical change governance.
Anforderungen
- Strategic leadership and standardization champion
- Ability to drive alignment across diverse groups
- Excellent communication skills
- Decisive accountability for manufacturing systems
- High degree of technical integrity
- Precision in managing complex changes
- Ensuring global equivalency in regulated environment
- Master’s degree in Engineering, Life Sciences, or related technical field
- PhD is a plus
- Minimum 10 years pharmaceutical/biotech experience
- Focus on multi-site operations and system standardization
- Deep expertise in managing complex equipment lifecycle
- Strong understanding of GMP
- Strong understanding of Quality Systems (PQS)
- Strong understanding of global regulatory requirements (ICH Q10, ICH Q12)
- Proven track record in leading change management
- Performing cross-site impact assessments in GMP environment
- Exceptional leadership skills
- Ability to influence decision-making
- Drive results across engineering, quality, site leadership
Aufgaben
- Champion the 'design one, build many' philosophy
- Provide strategic and operational oversight for fleet concept implementation
- Act as single point of accountability for DS and DP fleet equipment standards
- Establish and maintain robust governance for technical changes
- Approve comparative analyses of GMP-critical and process-critical systems
- Serve as primary contact for health authority interactions
- Manage master inventory and status of fleet equipment
- Own global lifecycle deliverables including validation plans, SOPs, and URS
- Lead impact analysis for changes to ensure consistent implementation
- Decide on new technical requirements and deployment timelines
Berufserfahrung
- 10 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- GMP
- Quality Systems (PQS)
- ICH Q10
- ICH Q12
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens F. Hoffmann-La Roche 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
F. Hoffmann-La Roche AG
Branche
Healthcare
Beschreibung
Das Unternehmen ist ein führender Anbieter von pharmazeutischen Wirkstoffen und setzt sich für die Gesundheitsversorgung weltweit ein.
Noch nicht perfekt?
- Roche
Head of Technology Strategy and Standards(m/w/x)
Vollzeitnur vor OrtManagementBasel - F. Hoffmann-La Roche AG
Quality Engineering Expert(m/w/x)
Vollzeitnur vor OrtSeniorBasel - F. Hoffmann-La Roche AG
Global MSAT Drug Substance Technology Deployment Steward(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Roche
Global MSAT Technology Deployment Group Lead(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Roche
Digital Quality Strategy Delivery Lead - Pharma Technical Operations(m/w/x)
Vollzeitnur vor OrtManagementBasel