Novartis Pharmaceutical Manufacturing GmbH
Global Head QA Operations Aseptics(m/w/x)
Vollzeitnur vor OrtSenior
Schaftenau
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NONovartis Pharmaceutical Manufacturing GmbH
Global Head QA Operations Aseptics(m/w/x)
Schaftenau
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Coordinating global Quality Units for sterile biopharmaceutical production. 15 years biopharmaceutical manufacturing QA experience required. Global coordination across multiple production sites.
Anforderungen
- Graduate in Chemistry, Pharmacy, Microbiology, Biotechnology, or related science
- 15 years experience in biopharmaceuticals manufacturing and Quality Assurance
- Operational knowledge of aseptic processing and medical device quality requirements
- Excellent GMP knowledge and aseptic environments
- QA/QC knowledge and solid experience with Authorities' inspections
- Fluent English (written and spoken)
Aufgaben
- Coordinate and support Quality Units
- Implement and develop Quality systems and programs
- Monitor Quality system performance
- Evaluate Quality performance using KPIs and reporting
- Report progress and issues to QA management
- Ensure timely follow-up on action plans
- Prepare, execute, and follow up on health authority inspections
- Determine trends for quality improvement
- Identify opportunities for quality improvement
- Support TpT and OTBA initiatives
- Act as NOSCEE SPOC
- Ensure alignment with global standards
- Guide organizational improvement and development
- Drive Operational Excellence
- Improve financial outcomes
- Drive harmonization initiatives across sites
- Drive process improvement initiatives across sites
- Act as Supply QA contact
- Support Annex 16 clarifications
- Manage artwork problems
- Implement follow-up measures for artwork problems
- Coordinate and support supplier certification programs
- Perform site compliance checks
- Support the site escalation process
- Support quality escalation processes
- Ensure timely communication of critical quality events
- Ensure robust resolution of critical quality events
Berufserfahrung
- 15 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- aseptic processing
- GMP
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Novartis Pharmaceutical Manufacturing 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 Pharmaceutical Manufacturing GmbH
Quality Team Leader QC(m/w/x)
Vollzeitnur vor OrtSeniorSchaftenauab 78.383,9 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
Senior Expert Science & Technology (Process Analytical Sciences)(m/w/x)
Vollzeitnur vor OrtManagementSchaftenauab 65.605,54 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
QA Compliance Expert – Sampling and Manufacturing(m/w/x)
Vollzeitnur vor OrtBerufserfahrenKundlab 64.023,54 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
Validation Lead(m/w/x)
Vollzeitnur vor OrtBerufserfahrenKundlab 60.212,18 / Jahr
NONovartis Pharmaceutical Manufacturing GmbH
Global Head QA Operations Aseptics(m/w/x)
Schaftenau
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Coordinating global Quality Units for sterile biopharmaceutical production. 15 years biopharmaceutical manufacturing QA experience required. Global coordination across multiple production sites.
Anforderungen
- Graduate in Chemistry, Pharmacy, Microbiology, Biotechnology, or related science
- 15 years experience in biopharmaceuticals manufacturing and Quality Assurance
- Operational knowledge of aseptic processing and medical device quality requirements
- Excellent GMP knowledge and aseptic environments
- QA/QC knowledge and solid experience with Authorities' inspections
- Fluent English (written and spoken)
Aufgaben
- Coordinate and support Quality Units
- Implement and develop Quality systems and programs
- Monitor Quality system performance
- Evaluate Quality performance using KPIs and reporting
- Report progress and issues to QA management
- Ensure timely follow-up on action plans
- Prepare, execute, and follow up on health authority inspections
- Determine trends for quality improvement
- Identify opportunities for quality improvement
- Support TpT and OTBA initiatives
- Act as NOSCEE SPOC
- Ensure alignment with global standards
- Guide organizational improvement and development
- Drive Operational Excellence
- Improve financial outcomes
- Drive harmonization initiatives across sites
- Drive process improvement initiatives across sites
- Act as Supply QA contact
- Support Annex 16 clarifications
- Manage artwork problems
- Implement follow-up measures for artwork problems
- Coordinate and support supplier certification programs
- Perform site compliance checks
- Support the site escalation process
- Support quality escalation processes
- Ensure timely communication of critical quality events
- Ensure robust resolution of critical quality events
Berufserfahrung
- 15 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- aseptic processing
- GMP
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Novartis Pharmaceutical Manufacturing 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 Pharmaceutical Manufacturing GmbH
Branche
Pharmaceuticals
Beschreibung
The company aims to reimagine medicine to improve and extend people’s lives.
Noch nicht perfekt?
- Novartis Pharmaceutical Manufacturing GmbH
Global Head QA Operations Aseptics(m/w/x)
Vollzeitnur vor OrtSeniorSchaftenau - Novartis Pharmaceutical Manufacturing GmbH
Quality Team Leader QC(m/w/x)
Vollzeitnur vor OrtSeniorSchaftenauab 78.383,9 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
Senior Expert Science & Technology (Process Analytical Sciences)(m/w/x)
Vollzeitnur vor OrtManagementSchaftenauab 65.605,54 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
QA Compliance Expert – Sampling and Manufacturing(m/w/x)
Vollzeitnur vor OrtBerufserfahrenKundlab 64.023,54 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
Validation Lead(m/w/x)
Vollzeitnur vor OrtBerufserfahrenKundlab 60.212,18 / Jahr