Head of Quality Swiss Affiliate
vor 2 Wochen
Wir suchen einen erfahrenen Head of Quality, der als fachtechnisch verantwortliche Person (FvP) die Qualität und Compliance eines global führenden Unternehmens im Bereich Allergie-Immuntherapie für die Schweizer Affiliate sicherstellt.
Aufgaben- Übernahme der Rolle der FvP inklusive Chargenfreigabe gemäß AMBV Art. 18 für den Schweizer Markt.
- Weiterentwicklung und Überwachung des Qualitätsmanagementsystems (QMS) in einem Unternehmen, das sich auf innovative Lösungen im Bereich Allergie-Immuntherapie spezialisiert hat.
- Sicherstellung der GDP-Prozesse sowie Überwachung der Lieferkette, um höchste Qualitätsstandards über alle Produktstufen hinweg zu gewährleisten.
- Funktion als Schweizer Bevollmächtigter (CH-REP) gemäß MepV für importierte Medizinprodukte.
- Leitung und Weiterentwicklung eines QA-Teams, das für die Qualitätssicherung und Pharmakovigilanz verantwortlich ist.
- Regelmäßige Audits und Inspektionen sowohl intern als auch von Gesundheitsbehörden, um die kontinuierliche Einhaltung der gesetzlichen Bestimmungen sicherzustellen.
- Enge Zusammenarbeit mit dem globalen Regulatory Affairs Team, um sicherzustellen, dass alle Produkte und Prozesse den internationalen Normen entsprechen.
- Sie arbeiten eng mit dem globalen Leadership Team zusammen, um die Qualitätssicherung in einem Unternehmen weiterzuentwickeln, das sich in einem stark wachsenden und regulierten Markt bewegt.
- Möglichkeit, die strategische Ausrichtung des Schweizer Standorts mitzugestalten und die Compliance-Standards weiter zu optimieren.
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