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 Manager (m/w/d) to support the establishment and management of an innovative pharmaceutical Quality Management System, including point-of-care activities. This activity is instrumental in facilitating and expanding the adoption of our groundbreaking products in hospitals worldwide. 

Responsibilities: 

Reporting to the Senior Director of Quality, the Quality Manager will provide essential support and domain area expertise to establish and operate an innovative cGxP Quality Management  System that is crucial to the delivery of the NVision mission, covering:

• The development, manufacturing, control, and distribution of NVision’s imaging injectable agents (including the devices and reagents necessary for their preparation)

• Quality processes for point-of-care operations supporting healthcare professionals who utilize our technologies. 

Key responsibilities:

Quality Management System (QMS): 

• Support the development, implementation, maintenance and continuous improvement of the company’s QMS in compliance with applicable GxP requirements and regulatory guidelines.

• Employ a risk-based approach in the design and operation of the QMS;  be responsible for the management of the Quality Risk Register 

• Lead the preparation and review of quality policies, SOPs, and documentation.

• Support the rollout,  embedding, and ongoing training of the QMS.

• Conduct risk assessment and mitigation initiatives to address and remediate quality issues across the product lifecycle.

• Support the implementation of an eQMS; act as administrator of the system.   

Regulatory Compliance and Audits:

• Manage a self-inspection process to assure compliance with internal systems, processes and applicable regulatory requirements. 

• Support the hosting of regulatory inspections, audits, and certifications to maintain compliance across all GxP operations.

Supplier and Partner Oversight:

• Support the management of supplier and partner qualification.

• Manage ongoing oversight of suppliers and partners in accordance with applicable agreements and regulatory requirements.

• Support the continuous improvement of supplier and partner quality.

Leading Quality Excellence:

• Lead by example in promoting and facilitating a culture of operational excellence and proactive quality management throughout the organization.

• Act as the company key point of contact for operation and training of the QMS.

• Work cross functionally to provide quality oversight, support and expertise in the conduct of quality related activities across development projects, employing Quality by Design (QbD) principles.