Novartis Business Services GmbH
Site Quality Head(m/w/x)
Vollzeitnur vor OrtSenior
Nürnberg, Halle (Saale), Dresden, Leipzig
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NONovartis Business Services GmbH
Site Quality Head(m/w/x)
Nürnberg, Halle (Saale), Dresden, Leipzig
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Directing quality operations and GxP/cGMP compliance for pharmaceutical production. 10 years GMP pharmaceutical manufacturing experience, including 3 years in QC/QA, required. Strategic leadership for quality initiatives.
Anforderungen
- BS/MSc in Life Sciences or related experience
- 10 years of experience in GMP Pharmaceutical Manufacturing
- At least 3 years of relevant experience in Quality Control or Quality Assurance
- Proven track record in supporting Quality Control operations
- In-depth knowledge of cGMP and FDA regulations
- Ability to manage multiple projects with moderate resource requirements
- Highly developed management and communication skills
- Strong organizational and time management skills
- Experience in process improvement approaches
Aufgaben
- Provide quality assurance oversight
- Support quality operations
- Lead technical and strategic quality initiatives
- Ensure compliance with GxP standards
- Ensure compliance with cGMP requirements
- Represent site quality in cross-functional and global project teams
- Lead and support the Quality Assurance department
- Ensure team members are qualified and motivated
- Create user requirements and specifications for projects
- Liaise with stakeholders for project coordination
- Ensure facilities and equipment are safe and compliant
- Oversee project planning, construction, and qualification phases
- Create and maintain project plans to track progress
- Escalate risks related to timelines and budgets
- Manage product critical quality issues and deviations
- Ensure effective execution of investigations and CAPAs
- Review and approve compliance-related notifications
- Define and monitor Site Quality KPIs
- Establish and support the Site Quality Committee
- Coordinate Site Quality Plans and risk assessments
- Prepare and consolidate the Quality Unit budget
- Ensure adherence to health and safety procedures
Berufserfahrung
- 10 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Novartis Business Services GmbH 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?
- Novartis Business Services GmbH
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Vollzeitnur vor OrtSeniorFeucht - CSL Plasma
Qualitätsmanagementbeauftragter(m/w/x)
Vollzeitnur vor OrtBerufserfahrenNürnberg - Novartis Pharma AG
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Vollzeitnur vor OrtKeine AngabeNürnberg
NONovartis Business Services GmbH
Site Quality Head(m/w/x)
Nürnberg, Halle (Saale), Dresden, Leipzig
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Directing quality operations and GxP/cGMP compliance for pharmaceutical production. 10 years GMP pharmaceutical manufacturing experience, including 3 years in QC/QA, required. Strategic leadership for quality initiatives.
Anforderungen
- BS/MSc in Life Sciences or related experience
- 10 years of experience in GMP Pharmaceutical Manufacturing
- At least 3 years of relevant experience in Quality Control or Quality Assurance
- Proven track record in supporting Quality Control operations
- In-depth knowledge of cGMP and FDA regulations
- Ability to manage multiple projects with moderate resource requirements
- Highly developed management and communication skills
- Strong organizational and time management skills
- Experience in process improvement approaches
Aufgaben
- Provide quality assurance oversight
- Support quality operations
- Lead technical and strategic quality initiatives
- Ensure compliance with GxP standards
- Ensure compliance with cGMP requirements
- Represent site quality in cross-functional and global project teams
- Lead and support the Quality Assurance department
- Ensure team members are qualified and motivated
- Create user requirements and specifications for projects
- Liaise with stakeholders for project coordination
- Ensure facilities and equipment are safe and compliant
- Oversee project planning, construction, and qualification phases
- Create and maintain project plans to track progress
- Escalate risks related to timelines and budgets
- Manage product critical quality issues and deviations
- Ensure effective execution of investigations and CAPAs
- Review and approve compliance-related notifications
- Define and monitor Site Quality KPIs
- Establish and support the Site Quality Committee
- Coordinate Site Quality Plans and risk assessments
- Prepare and consolidate the Quality Unit budget
- Ensure adherence to health and safety procedures
Berufserfahrung
- 10 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Novartis Business Services GmbH 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
Novartis Business Services GmbH
Branche
Pharmaceuticals
Beschreibung
The company is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities it serves.
Noch nicht perfekt?
- Novartis Business Services GmbH
Site Quality Head(m/w/x)
Vollzeitnur vor OrtSeniorNürnberg, Halle (Saale), Dresden, Leipzig - Novartis Business Services GmbH
HSE Head(m/w/x)
Vollzeitnur vor OrtSeniorHalle (Saale), Nürnberg - AGCO
Leiter Qualität(m/w/x)
Vollzeitnur vor OrtSeniorFeucht - CSL Plasma
Qualitätsmanagementbeauftragter(m/w/x)
Vollzeitnur vor OrtBerufserfahrenNürnberg - Novartis Pharma AG
Qualified Person Radiopharmaceuticals(m/w/x)
Vollzeitnur vor OrtKeine AngabeNürnberg