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.
Responsibilities:
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.