Senior Manager, R&D Quality Lead

vor 1 Monat

Marburg an der Lahn, Hessen, Deutschland CSL Vollzeit
Job Title: Senior Manager, R&D Quality

We are seeking a highly skilled and experienced Senior Manager, R&D Quality to join our team at CSL in Marburg. As a key member of our R&D Quality Management team, you will be responsible for managing the integration of R&D quality systems, policies, and procedures in line with our Global Quality Management System (QMS) for Product Development.

Key Responsibilities:
  • Develop and maintain Phase-appropriate Quality systems
  • Provide Quality oversight to the Product Development organisation for New Product Introduction, encompassing CSL and CMO manufactured and tested clinical material for Phase 1 & 2 and Phase 3 (where determined)
  • Manage the R&D quality unit to provide change control, batch technical release, deviation management, and risk management functions for Product Development in Marburg and Bern
  • Provide QA disposition on R&D deviations/CAPAs and Investigations for R&D clinical materials
  • Accountable for the QA team for the technical review and disposition of non-clinical toxicological material and clinical material
  • Management of the R&D self-inspection schedule for R&D functional areas
  • Assist with 3rd Party Quality audits as required to support Product Development
  • Drive and implement Quality Continuous Improvement Projects
  • Develop and build strong business relationships with local and global quality sites where manufacturing operations and shared between sites
  • Develop Quality Key Indicators with key PD stakeholders to ensure effectiveness of quality systems within Product Development
  • Attend and provide Quality oversight for Core Project Teams representing Quality for new Product Development projects as required
  • Manage performance and development of R&D Quality Advisors
  • Educate and inform R&D on international trends in quality and compliance in the pharmaceutical industry as they relate to biotechnology product development
  • Develop and implement 'Quality on the Floor' culture
Requirements:
  • Bachelor degree or Master degree
  • Experience in pharmaceutical manufacturing is highly desirable
  • Sound knowledge of GxP, domestic & international regulation, processes & registered condition
  • Experience and knowledge in the application of Quality Systems
  • Previous experience with personnel management
  • English language fluency, German language is a plus

We encourage you to apply for this challenging position if you have the necessary skills and experience. For further information, please contact Mandy Jergovic or Mareike Hammerstaedt, Senior Talent Acquisition Partner.

  • Senior Manager, R&D Quality Lead

    vor 4 Wochen

    Marburg an der Lahn, Hessen, Deutschland CSL Vollzeit

    Job DescriptionWe are seeking a highly skilled Senior Manager, R&D Quality to lead our R&D Quality Management team in Marburg. The successful candidate will be responsible for managing the integration of R&D quality systems, policies, and procedures in line with CSL Global Quality Management System (QMS) for Product Development.Key Responsibilities:Develop...

  • Senior Manager, R&D Quality Lead

    vor 3 Wochen

    Marburg an der Lahn, Hessen, Deutschland CSL Vollzeit

    Job SummaryWe are seeking a highly skilled Senior Manager, R&D Quality to lead our R&D Quality Management team in Marburg. The successful candidate will be responsible for managing the integration of R&D quality systems, policies, and procedures in line with CSL Global Quality Management System (QMS) for Product Development.Key ResponsibilitiesDevelop and...

  • Senior Manager, R&D Quality Lead

    vor 3 Wochen

    Marburg an der Lahn, Hessen, Deutschland CSL Vollzeit

    Job DescriptionWe are seeking a highly skilled Senior Manager, R&D Quality to join our team at CSL. The successful candidate will be responsible for managing the integration of R&D quality systems, policies, and procedures in line with our Global Quality Management System (QMS) for Product Development.Key ResponsibilitiesDevelop and maintain...

  • Senior Materials Engineer

    vor 3 Wochen

    Marburg an der Lahn, Hessen, Deutschland GULP – experts united Vollzeit

    On behalf of our business partner, we are currently seeking a highly skilled Senior Materials Engineer to lead our quality assurance efforts in the iron foundry industry. As a key member of our team, you will be responsible for ensuring the highest quality standards in our products and processes.Key Responsibilities:Develop and implement quality assurance...

  • QA Manager R&D Quality

    vor 1 Monat

    Marburg an der Lahn, Hessen, Deutschland CSL Vollzeit

    JobbeschreibungWir suchen einen erfahrenen QA Manager R&D für unsere Abteilung Quality in Marburg.AufgabenQualitätsführer in CMC-Team für neue Produktintroduktion-ProjekteErstellung der Qualitätsstrategie und Qualitätsführer in klinischen Produktintroduktion-Projekten von präklinischen Studien bis Phase IIIPlanung, Steuerung und Überwachung der...

  • QA Manager R&D Quality

    vor 1 Monat

    Marburg an der Lahn, Hessen, Deutschland CSL Vollzeit

    JobbeschreibungWir suchen einen erfahrenen QA Manager R&D für unsere Abteilung Quality in Marburg.AufgabenQualitätsführer in CMC-Team für neue Produktintroduktion-ProjekteErstellung der Qualitätsstrategie und Qualitätsführer in klinischen Produktintroduktion-Projekten von präklinischen Studien bis Phase IIIPlanung, Steuerung und Überwachung der...

  • Senior Associate Quality Assurance Spezialist

    vor 3 Wochen

    Marburg an der Lahn, Hessen, Deutschland CSL Behring Vollzeit

    Wir suchen eine erfahrene Person für die Position des Senior Associate Quality Assurance. In dieser Rolle sind Sie verantwortlich für die Einhaltung und Weiterentwicklung des Qualitätsmanagementsystems gemäß den lokalen und gesetzlichen Regularien.Als erster Ansprechpartner für RCB MBR (Research & Clinical Bioanalytics) in lokalen und globalen...

  • Senior Manager Downstream Development Lead

    vor 4 Wochen

    Marburg an der Lahn, Hessen, Deutschland CSL Vollzeit

    The OpportunityCSL Innovation is seeking a highly skilled and experienced Senior Manager to lead our Recombinant Process Development team. As a key member of our Biopharmaceutical Product Development (BPD) team, you will be responsible for providing scientific expertise and leadership for our downstream process development activities.The RoleLead the...

  • Senior Manager Downstream Development Lead

    vor 1 Monat

    Marburg an der Lahn, Hessen, Deutschland CSL Vollzeit

    The OpportunityWe are seeking a highly skilled and experienced Senior Manager to lead our Recombinant Process Development team at CSL. As a key member of our Biopharmaceutical Product Development (BPD) team, you will be responsible for providing scientific expertise and leadership for our downstream process development activities.The RoleLead the recombinant...

  • Senior Manager Downstream Development Lead

    vor 1 Monat

    Marburg an der Lahn, Hessen, Deutschland CSL Vollzeit

    The OpportunityWe are seeking a highly skilled and experienced Senior Manager to lead our Recombinant Process Development team at CSL. As a key member of our Biopharmaceutical Product Development (BPD) team, you will be responsible for providing scientific expertise and leadership for our downstream process development activities.The RoleLead the recombinant...

  • Quality and Materials Engineering Lead

    vor 3 Wochen

    Marburg an der Lahn, Hessen, Deutschland GULP – experts united Vollzeit

    As a key member of our team at GULP – experts united, we are seeking a highly skilled Quality and Materials Engineering Lead to join our organization. This role will be responsible for ensuring the highest quality standards in our products and processes.About the RoleDevelop and implement quality assurance strategies to meet customer...

  • Senior Manager Quality Control Marburg

    vor 4 Wochen

    Marburg an der Lahn, Hessen, Deutschland CSL Vollzeit

    Rolle und AufgabenWir suchen einen erfahrenen Senior Manager Quality Control Marburg, der unsere Abteilung Quality Control in Marburg leitet und die Durchführung von Analysen entsprechend den GMP-Regularien sicherstellt.Die Hauptaufgaben umfassen:Sicherstellung der GMP-konformen Durchführung und Dokumentation von qualitätsrelevanten PrüfungenPlanung,...

  • QA Manager R&D Quality m/f/x

    vor 4 Wochen

    Marburg an der Lahn, Hessen, Deutschland CSL Vollzeit

    Wir suchen einen erfahrenen Qualitätsmanager für unsere Abteilung R&D Qualität in Marburg. Als Leiter Qualitätsmanagement sind Sie verantwortlich für die Entwicklung und Umsetzung von Qualitätsstrategien und -prozessen in unseren Produktionsbereichen. Ihre Aufgaben:Qualitätslead in CMC-Team für neue ProduktintroduktionenErstellung der...

  • Senior Manager, Congress Planning Lead

    vor 3 Wochen

    Marburg an der Lahn, Hessen, Deutschland CSL Behring Vollzeit

    For our Business Excellence and Operations department, we are seeking a Senior Manager, Congress Planning to lead the logistical planning and execution of Above Market congresses.The ideal candidate will have 7+ years of experience in commercial roles in the pharmaceutical/biotech/medical device industry, with 3-5 years of relevant experience in planning and...

  • Senior Manager Downstream Development

    vor 3 Wochen

    Marburg an der Lahn, Hessen, Deutschland CSL Vollzeit

    For our Recombinant Process Development department, we are seeking a highly skilled and experienced Senior Manager to lead our downstream process development team.The OpportunityAs a Senior Manager, you will be responsible for providing technical expertise and leadership to the assigned team members, designing and developing state-of-the-art purification...

  • Senior Employee Relations Manager/in

    vor 3 Wochen

    Marburg an der Lahn, Hessen, Deutschland CSL Behring Vollzeit

    Senior Employee Relations Manager/inFür unseren Bereich Human Resources suchen wir eine/n Senior Employee Relations Manager/in (m/w/x) R-235152 Vollzeit / unbefristet / AT Sie fungieren als strategische/r Partner/in für das CSL-Management und agieren als Mentor/in innerhalb des ER-Teams. Als solche/r arbeiten Sie eng mit HR-Business Partnern, Managern,...

  • Senior Manager, Clinical Trial Supply Chain

    vor 4 Wochen

    Marburg an der Lahn, Hessen, Deutschland CSL Behring Vollzeit

    Senior Manager, Clinical Trial Supply ChainCSL Behring is seeking a highly skilled Senior Manager, Clinical Trial Supply Chain to lead the end-to-end supply chain for assigned clinical studies. The successful candidate will be responsible for managing the global network of regional and global depots to distribute drug supplies and ancillary supplies to...

  • Senior Manager, Clinical Trial Supply Chain

    vor 4 Wochen

    Marburg an der Lahn, Hessen, Deutschland CSL Behring Vollzeit

    Senior Manager, Clinical Trial Supply ChainCSL Behring is seeking a highly skilled Senior Manager, Clinical Trial Supply Chain to lead the end-to-end supply chain for assigned clinical studies. The successful candidate will be responsible for managing the global network of regional and global depots to distribute drug supplies and ancillary supplies to...

  • Senior Quality Control Manager Marburg

    vor 4 Wochen

    Marburg an der Lahn, Hessen, Deutschland CSL Vollzeit

    Jobbeschreibung:Wir suchen einen erfahrenen Senior Quality Control Manager für unsere Abteilung Quality Control in Marburg.Rolle:Leitung des Labors Mikrobiologie in der Qualitätskontrolle zur Durchführung von Analysen entsprechend den GMP-RegularienFührung des LaborpersonalsFachliche Verantwortung für die AnalysenmethodenLeiter der Qualitätskontrolle...

  • Senior Quality Control Manager Marburg

    vor 4 Wochen

    Marburg an der Lahn, Hessen, Deutschland CSL Vollzeit

    Jobbeschreibung:Wir suchen einen erfahrenen Senior Quality Control Manager für unsere Abteilung Quality Control in Marburg.Rolle:Leitung des Labors Mikrobiologie in der Qualitätskontrolle zur Durchführung von Analysen entsprechend den GMP-RegularienFührung des LaborpersonalsFachliche Verantwortung für die AnalysenmethodenLeiter der Qualitätskontrolle...