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Head of Quality Swiss Affiliate

vor 1 Monat


Zürich, Schweiz BTA Vollzeit
Head of Quality (w/m/d)Fachtechnisch verantwortliche Person (FvP)

Standort: Region Zürich


Über die Position:

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. In dieser strategisch wichtigen Rolle sind Sie Teil des Schweizer Leadership Teams und verantworten die Einhaltung der höchsten Qualitäts- und Regulierungsstandards, um Millionen von Patienten weltweit zu unterstützen. Ihre Arbeit wirkt sich direkt auf das Leben von Menschen aus, die von Allergien betroffen sind.

Ihre Aufgaben im Überblick:
  1. Übernahme der Rolle der FvP inklusive Chargenfreigabe gemäß AMBV Art. 18 für den Schweizer Markt.
  2. Weiterentwicklung und Überwachung des Qualitätsmanagementsystems (QMS) in einem Unternehmen, das sich auf innovative Lösungen im Bereich Allergie-Immuntherapie spezialisiert hat.
  3. Sicherstellung der GDP-Prozesse sowie Überwachung der Lieferkette, um höchste Qualitätsstandards über alle Produktstufen hinweg zu gewährleisten.
  4. Funktion als Schweizer Bevollmächtigter (CH-REP) gemäß MepV für importierte Medizinprodukte.
  5. Leitung und Weiterentwicklung eines QA-Teams, das für die Qualitätssicherung und Pharmakovigilanz verantwortlich ist.
  6. Regelmäßige Audits und Inspektionen sowohl intern als auch von Gesundheitsbehörden, um die kontinuierliche Einhaltung der gesetzlichen Bestimmungen sicherzustellen.
  7. Enge Zusammenarbeit mit dem globalen Regulatory Affairs Team, um sicherzustellen, dass alle Produkte und Prozesse den internationalen Normen entsprechen.
Ihre Entwicklungsmöglichkeiten:
  1. 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.
  2. Möglichkeit, die strategische Ausrichtung des Schweizer Standorts mitzugestalten und die Compliance-Standards weiter zu optimieren.
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