Quality Manager Pharmatech Industry mwd

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 pointofcare 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 missioncovering:

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

• Quality processes for pointofcare operations supporting healthcare professionals who utilize our technologies.

Key responsibilities:

Quality Management System (QMS):

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

• Employ a riskbased 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 selfinspection 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.

• At least 5 years of handson experience in quality assurance with a demonstrated ability to manage quality operations for injectable pharmaceuticals in the EU.

• Experience of shortshelf or point of care products (e.g. radiopharmaceuticals or ATMPs) is an advantage.

• Indepth 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 setup and management of thirdparty vendors and suppliers.

• Excellent problemsolving 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 crossfunctional team: experience collaborating with a diverse group of strong scientific and development experts.

• Fluent in English and German

• 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 fastgrowing 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 opendoor and open communications mentality

• Indefinite employment contract providing stability

• Longterm career growth opportunities

• 30 vacation days

• Relocation support

Join 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:

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 MRIbased imaging of realtime 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 easytouse hyperpolarization technology for preclinical and clinical research in our POLARIS product line. Those devices are placed close to an MRI scanner in a research or clinical environment to produce hyperpolarized contrast agents on demand in a fast fullyautomated multistep chemical process. Key steps of the process contain fluidic transport across multiple vessels and chemical mixing and separation processes in fullyreuseable or singleuse disposable fluid paths. We develop our commercial products jointly with external design and manufacturing partners and the process development as well as the design and manufacturing of prototypes is done entirely inhouse.

We offer a dynamic international working environment with immense room for growth that encourages personal initiative and open communication.