Aktuelle Jobs im Zusammenhang mit Head of Quality Systems - Ulm, Baden-Württemberg - NVision Imaging Technologies


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    Ulm, Baden-Württemberg, Deutschland NVision Imaging Technologies Vollzeit

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    Ulm, Baden-Württemberg, Deutschland NVision Imaging Technologies Vollzeit

    About the RoleWe are seeking an accomplished Head of Finance to join our dynamic team at NVision Imaging Technologies. As a thought partner to our leadership team, you will drive financial excellence, providing insightful recommendations through in-depth analysis and forward-thinking projections.Key Responsibilities:Develop and manage the annual budget,...

  • Head of Finance

    vor 4 Wochen


    Ulm, Baden-Württemberg, Deutschland NVision Imaging Technologies Vollzeit

    About the RoleWe are seeking an accomplished Head of Finance to join our dynamic team at NVision Imaging Technologies. As a thought partner to our leadership team, you will drive financial excellence, providing insightful recommendations through in-depth analysis and forward-thinking projections.Key Responsibilities:Develop and manage the annual budget,...


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  • Ulm, Baden-Württemberg, Deutschland KPMG Vollzeit

    Beschreibung der StelleWir suchen einen motivierten und engagierten Mitarbeiter, der sich für das System of Quality Management begeistert und sich in diesem Bereich weiterentwickeln möchte. Als Teil unseres Teams werden Sie an der Entwicklung und Umsetzung von Qualitätsmanagement-Systemen beteiligt sein.Aufgaben und VerantwortlichkeitenUnterstützung bei...


  • Ulm, Baden-Württemberg, Deutschland HENSOLDT Vollzeit

    Job SummaryHENSOLDT AG is seeking a highly skilled and experienced legal professional to join our team as Head of Legal Operations Radar. As a key member of our Legal Operations Radar department, you will be responsible for providing operational advice to our division management.Key ResponsibilitiesLead the Legal Operations Radar unit for the HENSOLDT Group,...

Head of Quality Systems

vor 2 Monaten


Ulm, Baden-Württemberg, Deutschland NVision Imaging Technologies Vollzeit
About the Role

This is a pivotal position for a Quality Director to play a key role in establishing and managing an innovative pharmaceutical quality system, including point-of-care activities. The successful candidate will lead the foundations and operations of NVision's cGXPs quality system, managing the two sides of our innovative use case:

  • Quality processes for the development, manufacturing, control, and distribution of NVision's imaging injectable agents, as well as the devices and reagents necessary for their compounding following the applicable regulatory and pharmaceutical quality requirements in the USA and EU.
  • Quality processes for point-of-care operations supporting healthcare professionals who utilize our technologies. These processes align with the innovative decentralized manufacturing framework currently built by health agencies worldwide.

The Quality Director will be responsible for building and leading an efficient Quality Assurance Team, providing oversight of the Quality Assurance Department, designing innovative quality programs and modalities, onboarding health agencies and hospital users, regulatory compliance and audits, supplier and partner oversight, and leading quality excellence.

Key Responsibilities
  • Quality System Development: Develop and implement a comprehensive quality system that meets regulatory requirements and industry standards.
  • Team Leadership: Build and lead a high-performing Quality Assurance Team, providing coaching, mentoring, and performance management.
  • Quality Process Improvement: Design and implement innovative quality processes and modalities to support decentralized manufacturing and point-of-care operations.
  • Regulatory Compliance: Ensure compliance with regulatory requirements in the USA and EU, including quality management systems and operations.
  • Supplier and Partner Management: Oversee the assessment and qualification of suppliers and partners, ensuring reliability and compliance of subcontracted components, materials, and services.
  • Quality Excellence: Foster a culture of quality excellence across NVision, promoting innovation, continuous improvement, risk mitigation, patient safety, and customer satisfaction.
Requirements
  • At least 10 years of hands-on experience in quality assurance, with a demonstrated ability to lead quality operations, specifically within the pharmaceutical, radiopharmaceutical, or drug-device combination sectors, in both EU and US markets.
  • Demonstrated ability to build and deliver a cGXPs quality system in the context of company/activity creation, product development, and/or company transformation.
  • Proven track record in leadership roles, driving quality excellence, impactful results, and onboarding of internal and external stakeholders.
  • Innovation mindset: comfortable in a startup environment, where problem-solving skills, organization skills, agility, and innovation are prized.
  • Familiarity with electronic Quality Management Systems (eQMS) and Application Lifecycle Management (ALM) for contracting, integration, and operational management.
  • Working in an international, interdisciplinary, and cross-functional team: experience collaborating with a diverse group of strong scientific and development experts.
  • Qualified Person (QP) possibility: proven track records, or the possibility to act as a QP in Germany, is considered an advantage.
About NVision Imaging Technologies

NVision Imaging Technologies is a quantum biotech startup based in Ulm, Germany, with Tier 1 investors from the USA and Europe. We are developing a technology that will enable MRI-based imaging of real-time metabolism in the body, with tremendous potential for research and applications in oncology, cardiology, neurology, and more. Our company brings together expertise in physics, chemistry, engineering, and medicine, and we are collaborating with scientists and clinicians from top medical and research centers.