Quality Director (Med/Pharmatech Industry) (m/w/d)

at  NVision Imaging Technologies

YOUR MISSION

Leveraging our unique know-how in pharmaceutical and quantum technologies, we are currently developing fast, robust and easy-to-use hyperpolarization technology for clinical application. Our devices are placed at the point of care, close to an MRI scanner in a clinical environment, to produce hyperpolarized contrast agents on demand for injection. The hyperpolarized solution is prepared in a fast, fully automated, multi-step process including chemical reactions, polarization transfer, and several purification steps.
As we successfully progress on this exciting journey and actively prepare the company for entry into the clinical stage, we are searching for a Quality Director (m/w/d) to play a pivotal role in establishing and managing an innovative pharmaceutical quality system, including point-of-care activities.
This activity is instrumental in facilitating and expanding the adoption of our groundbreaking products in hospitals worldwide.

ABOUT US

NVision is a quantum biotech startup based in Ulm, Germany, with Tier 1 investors from the USA and Europe. We are just leaving stealth mode, moving from local R&D to global commercialization and expansion.
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 such as Memorial Sloan Kettering in New York, MD Anderson in Texas, Technical University of Munich, Cambridge University in the UK and more.
NVision is developing fast, robust and easy-to-use hyperpolarization technology for preclinical and clinical research in our Polaris product line. Those devices are placed close to an MRI scanner in a clinical environment or a research lab to produce hyperpolarized contrast agents on demand. The hyperpolarized solution is prepared in a fast, fully-automated, multi-step process including chemical reactions, polarization transfer and several purification steps. We develop our commercial products in close collaboration with a product development partner, while the process development as well as the design of test setups and prototypes is done in-house.
We offer a dynamic international working environment, with immense room for growth, that encourages personal initiative and open communication.

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.

This mission plays a crucial role in executing NVision’s ambitious strategy and will be accomplished through the following steps:

• Building and leading an efficient Quality Assurance Team: this involves team creation, development, coaching, and mentoring, as well as performance and project management.
• Providing oversight of the Quality Assurance Department: ensuring that quality management systems and operations align with the company goals and deliver robust and effective results. This compliance extends to all applicable regulatory and quality requirements in the USA and EU for pharmaceuticals.
• Designing Innovative Quality Programs and Modalities: develop quality tools that enable decentralized manufacturing at the point of care, in hospitals. These initiatives can be based on software tools such as ALM/eQMS or integrated solutions within NVision devices, in partnership with NVision’s development team.
• Onboarding health agencies and hospital users during the implementation of these innovative quality approaches, supported by the CMC and Regulatory Affairs Department.
• Regulatory Compliance and Audits: prepare the organization for regulatory inspection audits. Ensure that all necessary documentation, procedures, and personnel comply with standards, working closely with the CMC and Regulatory Affairs department.
• Supplier and Partner Oversight: oversee the assessment and qualification of suppliers and partners, and guarantee the reliability and compliance of subcontracted components, materials, and services.
• Leading Quality Excellence: spearhead efforts to establish and maintain a culture of quality excellence across NVision, with a focus on innovation, continuous improvement, risk mitigation, patient safety and customer satisfaction.
• Environmental and HS Compliance: collaborate with the Manufacturing Operations to ensure NVision’s product compliance with environmental and health, safety, and environment (HSE) regulations.