Senior Quality Manager

Vor 6 Tagen

Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Vollzeit

For Daiichi Sankyo Europe GmbH we are seeking highly qualified candidates to fill the position:

Senior Quality Manager (m/f/d) CMO – Monoclonal Antibody Manufacturing

Purpose of the function:

In your new role you act as the primary contact for all quality related topics at contract manufacturing organizations (CMOs). As QM CMO you manage the quality oversight at the CMOs. Your responsibilities include implementation and maintaining of DS quality standards (GMP/GDP) and regulatory requirements at external contract manufacturers for our oncology products. Furthermore, you support other DS functions as an expert in quality topics and processes.

Roles and responsibilities:

  • Manage quality oversight at CMOs
  • You are responsible for quality related topics like change control, deviations and/or complaints related to DS products at CMOs
  • Define together with the CMO effective CAPAs and track the timely implementation
  • As DS QA you independently review, evaluate and approve documents like APQRs, PPQ reports or CPVs
  • The QM CMO is the person responsible for preparing and negotiating QAAs with CMOs and ensures the CMOs work in accordance with DS QAAs
  • You are involved in establishment of new manufacturing processes and site transfer activities and act as quality subject matter expert supporting PPQ and validation activities
  • You support CMOs during Authority Inspections and perform audits on behalf of DS at different suppliers as needed
  • In this role you identify quality risks at our CMOs and escalate issues in case it becomes necessary
  • Act as global information distributor
  • In your new role you support global teams and SMEs to identify and define quality needs for CMOs
  • You share quality related information from the CMOs to our global stakeholders within the global QA environment as well as in department overarching meetings
  • Participate in the further development of the corporate QM-System
  • In global working teams you act as SME to improve the DS quality system and global SOP landscape
  • Share knowledge and expertise within QA or to other functions to improvement CMO management at DS

In this role you will work globally in close cooperation with other departments like Supply Chain, CMC, regulatory functions and others to ensure consistent supply to markets with products which meet our high quality standards at any time.

Personal skills and professional experience:

  • University/FH/Master degree in natural or pharmaceutical sciences - preferred in Biotechnology, Bioengineering, Biochemistry or a comparable program
  • At least five years of relevant work experience in the pharmaceutical industry including:
  • at least two years in Quality Assurance and/or Quality Management – preferable in Shop Floor QA activities or as QA Oversight for Manufacturing Activities
  • at least two years in a GxP environment in a position involved in monoclonal antibody manufacturing
  • Excellent knowledge of international GMP/GDP regulations
  • Have assertiveness, strong communication skill paired with diplomatic attitude during negotiations
  • A true team player, high quality consciousness and a solution-oriented mindset
  • Very good written and verbal communication skills in English and German
  • Experience with managing CMOs or external suppliers is beneficial
  • Project management skills is a plus
  • Willingness to travel (up to 10%, domestic and international)

Apply now

  • Expert (m/f/x) CMO Quality Management

    vor 1 Woche

    Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Vollzeit

    For Daiichi Sankyo Europe GmbH we are seeking highly qualified candidates to fill the position:Expert (m/f/x) CMO Quality ManagementPurpose of the function:In your new role you support the primary contact for quality related topics (CMO-MQ) at contract manufacturing organizations (CMOs). You support the management of the quality oversight at the CMOs, which...

  • Expert (m/f/d) CMO Quality Management

    vor 1 Woche

    Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Vollzeit

    For Daiichi Sankyo Europe GmbH we are seeking highly qualified candidates to fill the position:Expert (m/f/d) CMO Quality ManagementPurpose of the function:In your new role you support the primary contact for quality related topics (CMO-MQ) at contract manufacturing organizations (CMOs). You support the management of the quality oversight at the CMOs, which...

  • Quality Assurance Assistant/in

    vor 1 Woche

    Pfaffenhofen an der Ilm, Deutschland Daiichi-Sankyo Europe Vollzeit

    Unterstützung für den QA Bereich in der Abteilung Qualitätskontrolle in diversen Aufgaben im GMP und Quality Assurance Umfeld. - Einsatzzeit: voraussichtlich 2 Jahr in Vollzeit **Aufgaben als QA Manager Assistent/in**: - Sicherstellung der Einhaltung von GMP-Regularien - Arbeiten mit Datenbänken für Audits und Qualifizierungen - Übernahme von...

  • Senior Associate

    Vor 2 Tagen

    Marburg an der Lahn, Deutschland CSL Behring Vollzeit

    Für unseren Bereich Quality in Marburg suchen wir aktuell eine/n **Senior Associate Quality Assurance**(m/w/x)**: R-248604 Vollzeit / unbefristet Als erster Ansprechpartner für RCB MBR (Research & Clinical Bioanalytics) in lokalen und globalen Multisite GLP-Studien sorgt diese Person für die Einhaltung und Weiterentwicklung des...

  • Global Engineering Quality Manager

    Vor 6 Tagen

    Heidenheim an der Brenz, Baden-Württemberg, Deutschland Voith Group Vollzeit

    Über die Voith GroupDie Voith Group ist ein weltweit agierender Technologiekonzern. Mit seinem breiten Portfolio aus Anlagen, Produkten, Serviceleistungen und digitalen Anwendungen setzt Voith Maßstäbe in den Märkten Energie, Papier, Rohstoffe und Transport & Automotive. Gegründet 1867 ist Voith heute mit rund Mitarbeiterinnen und Mitarbeitern, 5,2...

  • Quality And Environmental Manager

    vor 4 Wochen

    Bad Homburg vor der Höhe, Deutschland Gold Group Ltd Vollzeit 60.000 € - 70.000 €

    Quality & Safety Manager Location: Bad Homburg, Germany Salary: €60,000 - €70,000 + excellent benefits Join a globally respected innovator whose high-precision technologies support researchers and scientists around the world. If you're passionate about quality, safety, and continuous improvement, and want your expertise to contribute to meaningful...

  • Senior Quality Specialist M/w/x

    Vor 2 Tagen

    Marburg an der Lahn, Deutschland CSL Behring Vollzeit

    Für unsere Abteilung **Quality Assurance **in Marburg suchen wir aktuell einen Senior Quality Specialist (m/w/x) R-243376 Vollzeit / unbefristet/ Tarif Interner Job Titel: Senior Quality Specialist Internes Ausschreibungsende: 09.10.2024 Sie sind im Bereich Quality involviert in den APQR, die Abweichungsbearbeitung und die Inspektionen. Sie stellen...

  • Senior Quality Specialist

    Vor 2 Tagen

    Marburg an der Lahn, Deutschland Hays Vollzeit

    **Senior Quality Specialist** (m/w/d) **Anstellung bei der Hays Professional Solutions GmbH** **Marburg** **Startdatum: sofort** Referenznummer: 755652/1 **Bewerbung starten** **Ihre Aufgaben**: - Qualitätsmanagement (Quality Oversight) im Verantwortungsbereich unter allgemeiner Anleitung des Vorgesetzten - Fortlaufende Betreuung und...

  • Senior Quality Specialist

    Vor 2 Tagen

    Marburg an der Lahn, Deutschland Oxford Global Resources Vollzeit

    Location: Marburg, Germany - Contact: Jessica Kolbert - Job type: Temp to Perm - Industry: Pharmaceutical Werden Sie Teil eines dynamischen Teams bei einem unserer Kunden als Senior Quality Specialist und tragen Sie zum Engagement des Unternehmens für Spitzenleistungen bei! In dieser Funktion sind Sie an vorderster Front für die Überwachung der Qualität...

  • Senior Quality Specialist

    vor 2 Wochen

    Marburg an der Lahn, Deutschland CSL Vollzeit 60.000 € - 120.000 € pro Jahr

    Für unsere Abteilung Quality Assurance in Marburg suchen wir aktuell eine/nSenior Quality Specialist mit Führungsverantwortung (m/w/x)R-264115Vollzeit / unbefristetDie AufgabeSie entwickeln und fördern die Ihnen unterstellten MitarbeiterInnen und motivieren Ihr TeamSie führen Mitarbeitereinzelgespräche nach Bedarf (bspw. Fürsorgegespräche oder...