Semdor Pharma Group GmbH
QA/QC Manager(m/w/x)
Vollzeitmit HomeofficeSenior
Köln
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
MIMiltenyi Biotec
Senior Quality Assurance Manager – External Manufacturing (Cell Therapies)(m/w/x)
Bergisch Gladbach
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Quality oversight for external cell therapy manufacturing, including technical transfers and GMP compliance. Several years of operational QA experience in GMP-regulated pharma/biotech required. Flexible remote work, international teams.
Anforderungen
- University degree (bachelor's or higher) in relevant scientific/technical discipline
- Several years of experience in operational QA/Quality Systems in GMP-regulated pharma/biotech
- Thorough understanding of global GMP/GDP regulatory requirements
- Knowledge/experience with ATMPs related operations and requirements
- Proven track record supporting/facilitating technical transfer activities
- Profound understanding of technical transfer regulatory/operational requirements
- Hands-on experience in QA oversight of external manufacturing partners
- Experience with third-party management
- Interacting/collaborating with Pharma clients in international environment
- Successfully leading regulatory inspections
- Managing/resolving global issues
- Experience building/maintaining adequate Pharma QMS
- Strong drive to establish a new role
- Ability to develop, implement, embed structures/processes
- Proactive and solution-oriented
- Passion for shaping the future
- Excellent communication skills
- Ability to collaborate effectively with diverse stakeholders
- Initial experience in a leadership role
Aufgaben
- Ensure quality and regulatory compliance for external pharmaceutical manufacturing
- Provide Quality Assurance oversight for cell therapy manufacturing
- Support technical transfers of pharmaceutical products
- Align internal and external manufacturing activities and quality expectations
- Investigate and resolve quality-related issues impacting product quality and safety
- Contribute to the development and maintenance of the Global Quality Management System
- Collect and report Quality KPIs
- Perform Quality Management Reviews (QMRs)
- Author Annual Product Quality Reviews (APQRs)
- Support third-party qualification and auditing activities
- Conduct regulatory inspections and customer audits at external sites
- Review and provide input to regulatory documentation
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- GMP
- GDP
- ATMPs
- QMS
- FDA
- EMA
- ICH
Benefits
Flexibles Arbeiten
- Flexible remote work
Lockere Unternehmenskultur
- International teams
- Cross-border intercultural communication
Gesundheits- & Fitnessangebote
- Corporate sports activities
- Health provision
Weiterbildungsangebote
- In-house Training Academy
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Miltenyi Biotec 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.
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MIMiltenyi Biotec
Senior Quality Assurance Manager – External Manufacturing (Cell Therapies)(m/w/x)
Bergisch Gladbach
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Quality oversight for external cell therapy manufacturing, including technical transfers and GMP compliance. Several years of operational QA experience in GMP-regulated pharma/biotech required. Flexible remote work, international teams.
Anforderungen
- University degree (bachelor's or higher) in relevant scientific/technical discipline
- Several years of experience in operational QA/Quality Systems in GMP-regulated pharma/biotech
- Thorough understanding of global GMP/GDP regulatory requirements
- Knowledge/experience with ATMPs related operations and requirements
- Proven track record supporting/facilitating technical transfer activities
- Profound understanding of technical transfer regulatory/operational requirements
- Hands-on experience in QA oversight of external manufacturing partners
- Experience with third-party management
- Interacting/collaborating with Pharma clients in international environment
- Successfully leading regulatory inspections
- Managing/resolving global issues
- Experience building/maintaining adequate Pharma QMS
- Strong drive to establish a new role
- Ability to develop, implement, embed structures/processes
- Proactive and solution-oriented
- Passion for shaping the future
- Excellent communication skills
- Ability to collaborate effectively with diverse stakeholders
- Initial experience in a leadership role
Aufgaben
- Ensure quality and regulatory compliance for external pharmaceutical manufacturing
- Provide Quality Assurance oversight for cell therapy manufacturing
- Support technical transfers of pharmaceutical products
- Align internal and external manufacturing activities and quality expectations
- Investigate and resolve quality-related issues impacting product quality and safety
- Contribute to the development and maintenance of the Global Quality Management System
- Collect and report Quality KPIs
- Perform Quality Management Reviews (QMRs)
- Author Annual Product Quality Reviews (APQRs)
- Support third-party qualification and auditing activities
- Conduct regulatory inspections and customer audits at external sites
- Review and provide input to regulatory documentation
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- GMP
- GDP
- ATMPs
- QMS
- FDA
- EMA
- ICH
Benefits
Flexibles Arbeiten
- Flexible remote work
Lockere Unternehmenskultur
- International teams
- Cross-border intercultural communication
Gesundheits- & Fitnessangebote
- Corporate sports activities
- Health provision
Weiterbildungsangebote
- In-house Training Academy
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Miltenyi Biotec 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.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Miltenyi Biotec
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen entwickelt einzigartige Lösungen für die biomedizinische Spitzenforschung sowie neuartige Zell- und Gentherapien.
Noch nicht perfekt?
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