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Open nowPosted 99 days ago

QC Compliance Group Leader

almirall53 open roles

Where
REINBEK
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Your applicationOpen nowQC Compliance Group Leaderalmirall · REINBEK

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The clock on this job

Early applications get read.

12.7% of postings close within 7 days. Measured by our own scanner across the market. almirall postings stay open a median of 14 days.

Share of postings closed within
  1. 2.2%1 day
  2. 4.5%3 days
  3. 12.7%7 days
  4. 20.4%14 days
  5. 35.6%30 days
  6. 58.7%60 days
This job: posted 99 days ago

almirall median: 14 days open

The posting

We’re building the future of medical dermatology by focusing on unmet patient needs and giving people the space to think independently, take ownership and make an impact that matters.

Our purpose is simple: to transform patients’ lives by addressing real needs. We work with care, act with courage, keep things simple and focus our innovation where it makes a difference.

Recognised as a Top Employer in Spain since 2008 and in Germany since 2025, we continue to invest in an environment where people can grow and move forward.

If you care differently, you belong here.

Ihr Beitrag

In dieser Schlüsselposition übernehmen Sie die Leitung der Stabilitätsgruppe und stellen die GMP-konforme Bearbeitung qualitätsrelevanter Prozesse sicher. Sie verantworten die Bewertung von Stabilitätsdaten, unterstützen bei regulatorischen Fragestellungen und führen die Erstellung sowie Optimierung von Qualitätsdokumenten. Darüber hinaus entwickeln Sie das QC Instrument Management Team weiter und stellen die effiziente Betreuung des QC-Geräteparks und der Prüfmittelüberwachung sicher.

Ihre Aufgaben

  • Organisation unserer Stabilitätsgruppe mit Fokus auf Compliance relevante Themen:
  • OOS-, Deviation-, CAPA-, Change Control- Bearbeitung
  • Freigabe und finaler Review der GMP Dokumentation
  • Erkennen, bewerten und Risikobetrachtung von Trends in Bezug auf Stabilitätsdaten
  • Mitarbeit bzw. Beantwortung von regulatorischen Anfragen inkl. Bearbeitung von Mängelrügen
  • Koordination der Überarbeitung bzw. Erstellung von Prüfanweisungen, SOPs für den Fachbereich
  • Betreuen und entwickeln des QC Instrument Management Teams (Prüfmittelüberwachung) und den zugehörigen Aufgaben (Betreuung des QC Geräteparks inkl. Wartung, Qualifizierung und Neubeschaffung)

Das bringen Sie mit

  • Naturwissenschaftliches Studium (z. B. Chemie, Chemieingenieurwesen oder vergleichbar) sowie mindestens 2 Jahre Berufserfahrung in der Pharmaindustrie.
  • Sehr gute GMP-Kenntnisse und fundierte Erfahrung in der instrumentellen Analytik, insbesondere HPLC.
  • Führungserfahrung sowie die Fähigkeit, Teams zu motivieren, weiterzuentwickeln und erfolgreich zu führen.
  • Souveränes Auftreten in Präsentationen und Besprechungen sowie ausgeprägte Kommunikations- und Durchsetzungsstärke.
  • Innovationsfreude, Teamgeist und eine lösungsorientierte Arbeitsweise.
  • Wünschenswert sind Kenntnisse in halbfesten Arzneiformen, Stabilitätsprüfung, Prüfmittelüberwachung, GAMP, Data Integrity sowie KI-gestützten Anwendungen.

Unsere Benefits

  • 37,5 Stundenwoche
  • Bis zu 35 Tage Urlaub
  • Betriebliche Altersvorsorge & Vermögenswirksame Leistungen
  • Betriebliche Krankenzusatzversicherung
  • Mitarbeiterkantine
  • Unternehmens-Unfall- und Reiseversicherung
  • Familien-Benefits: Sonderurlaub "kind krank" und Kindernotfallbetreuung
  • Leistungsbasiertes Bonussystem / Prämiensystem
  • Gesundheitsförderung (Urban Sports, Bike-Leasing)
  • Fort- und Weiterbildungsmöglichkeiten
  • Mitarbeiterevents
  • Mitarbeiterrabatte beim Personalverkauf

Leitung der Compliance / Stabilitätsgruppe in der QC. Sicherstellung der QC GMP Compliance im Bereich Stabilitätskontrolle / Gerätemanagement und Dokumentation

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