Manager, Head of Regulatory Compliance
vor 1 Woche
Für den Bereich QA Compliance / Gruppe Regulatory Compliance innerhalb unseres Departements Quality suchen wir ab sofort oder nach Vereinbarung eine/n
**Manager Quality Compliance 100 % (m/w/d)**
**Ihre Aufgaben beinhalten im Wesentlichen, aber nicht ausschliesslich**:
- Koordinieren, Überprüfen und Beantworten von Kunden
- und Behördenanfragen
- Vorbereiten, Organisieren und Betreuen von Kunden
- und Behördeninspektionen (national und international)
- Vorbereiten und Durchführen von standortinternen Audits
- Regelmässiges Update der GMP-relevanten Dokumente (z.B. Site Master File)
- CSL interne Unterstützung in qualitätsrelevanten Fragen
- Mitarbeit in verschiedenen Projekten und Initiativen (bei Bedarf)
- Teamführung
**Sie bringen die folgenden Qualifikationen und Kompetenzen mit**:
- Universitäts
- bzw. Fachhochschulabschluss im Bereich Life Sciences (z.B. Pharmazie, Biologie oder Chemie) oder äquivalent
- Mindestens 3 Jahre Berufserfahrung im GMP Bereich eines pharmazeutischen Unternehmens
- Erfahrung bei der Durchführung von Audits und in der aseptischen Arbeitsweise sind von Vorteil
- Erfahrung in der Teamführung
- Kenntnisse der cGMP-Richtlinien und deren Umsetzung
- Fähigkeit mehrere Aufgaben gleichzeitig anzugehen und in hektischen Situationen den Überblick zu behalten
- Vernetztes Denken und eine exakte und analytische Arbeitsweise
- Proaktive Persönlichkeit, die klar und offen kommuniziert und es versteht Beziehungen zu Anspruchsgruppen unterschiedlicher Fachrichtungen zu pflegen
- Verhandlungssichere Deutsch
- und sehr gute Englischkenntnisse (in Wort und Schrift)
Fühlen Sie sich angesprochen? Dann freuen wir uns auf Ihre Online-Bewerbung. Ihre Bewerbung sollte ein Motivationsschreiben, einen Lebenslauf/CV sowie Arbeitszeugnisse und Kopien von Diplomen in der Originalsprache und/oder relevante Transkripte beinhalten. Bitte fügen Sie Ihre Dateien, inklusive CV, zu einem Dokument zusammen.
CSL Behring verpflichtet sich dem Prinzip der Chancengleichheit.
**Our Benefits**:
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
**About CSL Behring**:
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
**We want CSL to reflect the world around us**:
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
**Do work that matters at CSL Behring**:
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