Quality Manager
Vor 3 Tagen
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.
Your profileAt least 5 years of hands-on experience in quality assurance, with a demonstrated ability to manage quality operations for injectable pharmaceuticals in the EU.
Experience of short-shelf or point of care products (e.g. radiopharmaceuticals or ATMPs) is an advantage.
In-depth knowledge of GMP and relevant pharmaceutical regulations in the EU with experience of FDA an advantage. A broader knowledge of GLP and medical devices is desirable, but not essential.
Demonstrated experience in the development and continuous improvement of cGxP quality systems.
Experience in the set-up and management of third-party vendors and suppliers.
Excellent problem-solving, analytical, and communication skills.
Innovation mindset: comfortable in a startup environment where proactivity, 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.
Fluent in English and German
Why us?Competitive compensation, based on base salary and stock options
Onsite in a modern office/lab environment with flexible Home Office options
Key role in a highly advanced and fast-growing startup company
Ample opportunity for personal initiatives, openness to new ideas and room for considerable personal impact
Impactful product promoting better understanding and treatment of disease
International team, from over 20 different nationalities
Enjoyable work atmosphere with an open-door and open communications mentality
Indefinite employment contract, providing stability
Long-term career growth opportunities
30 vacation days
Relocation support
contact informationJoin us in making a difference Submit your application to be considered for this exciting opportunity.
Any questions? Please contact:
Emilija Stojanovska
Talent Acquisition Manager
mail: careers@nvision-imaging.com
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.
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