GMP Qualification Project Manager

vor 3 Monaten


Singen, Baden-Württemberg, Deutschland BakerHicks Vollzeit

Position Overview:

The role involves the autonomous planning and oversight of global investment initiatives, ensuring adherence to current Good Manufacturing Practice (GMP) standards and regulatory frameworks.

Key Responsibilities:

  • Directing cross-functional teams for the execution of commissioning and qualification projects.
  • Facilitating effective communication among all project stakeholders.
  • Delivering expert compliance services and consultancy.
  • Timely development and documentation of GMP-compliant qualification, validation, and commissioning strategies.
  • Coordinating and executing system and equipment conformity assessments.

Qualifications:

  • A degree in a relevant scientific or engineering discipline.
  • Proven experience in project management within the pharmaceutical sector.
  • Demonstrated leadership abilities in managing teams and projects.
  • Strong foundation in qualification, validation, corrective and preventive actions (CAPA), deviations, and change management.
  • Experience in drafting proposals and specifications for tenders.
  • Ability to work independently with a structured and quality-focused approach.
  • Fluent in both German and English.
  • Willingness to travel extensively within the DACH region.

Benefits:

  • Company-provided mobile phone and laptop.
  • 30 days of annual leave.
  • Attractive employer-sponsored retirement plan.
  • Financial assistance for home office setup.
  • Flexible working hours.
  • Flat organizational structure.
  • Commitment to the highest standards of occupational safety.
  • Employee referral incentives.
  • Options for part-time work.
  • Global travel insurance coverage.
  • Possibility for unpaid leave.
  • No mandatory office attendance required.
  • Fully compensated overtime.
  • Travel time recognized as working hours.
  • Remote work options available.
  • Comprehensive expense reimbursement policy.
  • Company-sponsored fitness initiatives.


  • Singen, Baden-Württemberg, Deutschland BakerHicks Vollzeit

    Position Overview:The role involves the autonomous planning and oversight of global investment initiatives adhering to the latest Good Manufacturing Practice (GMP) standards and regulatory frameworks.Key Responsibilities:Manage and direct cross-functional teams for the execution of commissioning and qualification projects.Facilitate effective communication...


  • Singen, Baden-Württemberg, Deutschland BakerHicks Vollzeit

    Position Overview:The role involves the autonomous planning and oversight of global investment initiatives adhering to the latest Good Manufacturing Practice (GMP) standards and regulatory frameworks.Key Responsibilities:Manage and direct cross-functional teams for the execution of commissioning and qualification projects.Facilitate effective communication...


  • Singen, Baden-Württemberg, Deutschland Takeda GmbH Vollzeit

    Join Takeda GmbH as a Process Engineer ProjectsAbout the Role:Takeda GmbH is seeking a highly skilled Process Engineer Projects to join our team in Singen, Germany. As a key member of our Technical Operations team, you will play a critical role in the global production of vaccines.Key Responsibilities:Manage technical aspects of global drug product...


  • Singen, Baden-Württemberg, Deutschland Takeda Vollzeit

    Herstellungs-Compliance-Manager (w/m/d)Wir suchen nach einem erfahrenen Herstellungs-Compliance-Manager, der unsere Produktion von Arzneimitteln sicher und qualitativ hochwertig gestalten kann.Deine Aufgaben:Verantwortung für die Einhaltung der Prozess- und GMP-Richtlinien gemäß behördlichen und Takeda-VorgabenImplementierung, Koordination und...


  • Singen, Baden-Württemberg, Deutschland Takeda Vollzeit

    Herstellungs-Compliance-Manager (w/m/d)Wir suchen nach einem erfahrenen Herstellungs-Compliance-Manager, der unsere Produktion von Arzneimitteln sicher und qualitativ hochwertig gestalten kann.Deine Aufgaben:Verantwortung für die Einhaltung der Prozess- und GMP-Richtlinien gemäß behördlichen und Takeda-VorgabenImplementierung, Koordination und...


  • Singen, Baden-Württemberg, Deutschland Takeda GmbH Vollzeit

    Job Title: Process Engineer Projects SpecialistAbout the Role:We are seeking a highly skilled Process Engineer Projects Specialist to join our team at Takeda GmbH. As a key member of our Technical Operations department, you will be responsible for managing technical aspects of global drug product manufacturing within Vaccines Technical Operations.Key...


  • Singen, Baden-Württemberg, Deutschland Takeda GmbH Vollzeit

    Job SummaryWe are seeking a highly skilled Process Engineer to join our team in Singen, Germany. As a Process Engineer for Vaccine Production, you will be responsible for managing technical aspects of global drug product manufacturing within Vaccines Technical Operations.Your main responsibilities will include driving continuous improvements across...


  • Singen, Baden-Württemberg, Deutschland Takeda Vollzeit

    Herstellungs-Compliance-Manager (w/m/d)Wir suchen einen erfahrenen Herstellungs-Compliance-Manager, der unsere Produktion von Impfstoffen und Biopharmazeutika sicher und qualitativ hochwertig gestalten kann.Deine Aufgaben:Verantwortung für die Einhaltung der Prozess- und GMP-Richtlinien gemäß behördlichen und Takeda-VorgabenImplementierung, Koordination...


  • Singen, Baden-Württemberg, Deutschland Takeda Vollzeit

    Herstellungs-Compliance-Manager (w/m/d)Wir suchen einen erfahrenen Herstellungs-Compliance-Manager, der unsere Produktion von Impfstoffen und Biopharmazeutika sicher und qualitativ hochwertig gestalten kann.Deine Aufgaben:Verantwortung für die Einhaltung der Prozess- und GMP-Richtlinien gemäß behördlichen und Takeda-VorgabenImplementierung, Koordination...


  • Singen, Baden-Württemberg, Deutschland Takeda Vollzeit

    About the RoleWe are seeking a highly skilled Process Engineer Drug Product to join our team in Singen, Germany. As a key member of our Vaccines Technical Operations team, you will be responsible for managing technical aspects of global drug product manufacturing, driving continuous improvements across commercial sites in the Takeda network.Key...


  • Singen, Baden-Württemberg, Deutschland Takeda Vollzeit

    Embark on a career-defining opportunity as a Product Development Engineer Vaccine Manufacturing with Takeda in Singen, Germany. About the RoleWe are seeking an exceptional individual to join our team and drive the development of vaccine manufacturing processes. As a Product Development Engineer Vaccine Manufacturing, you will be responsible for managing...


  • Singen, Baden-Württemberg, Deutschland Takeda Vollzeit

    About the RoleWe are seeking a highly skilled Process Engineer to join our team in Singen, Germany. As a Process Engineer, you will play a key role in the development and implementation of new manufacturing processes for our vaccine products.Key ResponsibilitiesManage technical aspects of global drug product manufacturing within Vaccines Technical...


  • Singen, Baden-Württemberg, Deutschland Takeda Vollzeit

    About the RoleWe are seeking a highly skilled Process Engineer to join our team in Singen, Germany. As a Process Engineer, you will play a key role in the development and implementation of new manufacturing processes for our vaccine products.Key ResponsibilitiesManage technical aspects of global drug product manufacturing within Vaccines Technical...


  • Singen, Baden-Württemberg, Deutschland Takeda Vollzeit

    DescriptionTakeda is seeking a skilled Process Engineer Drug Product to join our team in Singen, Germany. In this role, you will be responsible for managing technical aspects of global drug product manufacturing within Vaccines Technical Operations, driving continuous improvements across commercial sites in the Takeda network.Your Key Responsibilities:Manage...


  • Singen, Baden-Württemberg, Deutschland BakerHicks Vollzeit

    Ihre AufgabenInternationale Investitionsprojekte planen und leiten, unter Berücksichtigung aktueller GMP-Vorgaben und regulatorischer RichtlinienInterdisziplinäre Teams führen, um Inbetriebnahme- und Qualifizierungsprojekte erfolgreich zu gestaltenProjektkommunikation sicherstellen, um alle Stakeholder zu informierenTechnische Compliance-Dienstleistungen...


  • Singen, Baden-Württemberg, Deutschland BakerHicks Vollzeit

    Ihre AufgabenDie Planung und Leitung internationaler Investitionsprojekte unter Berücksichtigung aktueller GMP-Vorgaben sowie regulatorischer und kundeninterner RichtlinienDie Führung von interdisziplinären Teams im Rahmen von Inbetriebnahme- und QualifizierungsprojektenDie Sicherstellung der Projektkommunikation zu allen StakeholdernDie Erbringung von...


  • Singen, Baden-Württemberg, Deutschland BakerHicks Vollzeit

    Ihre AufgabenDie Planung und Leitung internationaler Investitionsprojekte unter Berücksichtigung aktueller GMP-Vorgaben sowie regulatorischer und kundeninterner RichtlinienDie Führung von interdisziplinären Teams im Rahmen von Inbetriebnahme- und QualifizierungsprojektenDie Sicherstellung der Projektkommunikation zu allen StakeholdernDie Erbringung von...


  • Singen, Baden-Württemberg, Deutschland Takeda Vollzeit

    Deine Rolle:Als Manufacturing Compliance Manager bei Takeda bist du verantwortlich für die Einhaltung von Prozess- und GMP-Richtlinien. Du wirst in enger Zusammenarbeit mit der Qualitätssicherung und der Qualitätskontrolle tätig sein und sicherstellen, dass alle Herstellungsprozesse den gesetzlichen Anforderungen entsprechen.Deine...


  • Singen, Baden-Württemberg, Deutschland Takeda GmbH Vollzeit

    At Takeda GmbH, we are seeking a highly skilled Process Engineer to join our team in Singen, Germany. As a Process Engineer for Global Vaccine Production, you will play a crucial role in managing technical aspects of global drug product manufacturing within Vaccines Technical Operations.Main ResponsibilitiesDrive continuous improvements across commercial...


  • Singen, Baden-Württemberg, Deutschland Takeda GmbH Vollzeit

    Join Takeda GmbH as a Senior Vaccine Process EngineerAre you passionate about developing innovative vaccine manufacturing processes? Do you have a strong background in chemical engineering and experience in managing technical projects? We are looking for a skilled Technical Operations Manager - Vaccines to oversee the implementation of advanced technologies...