NVision Imaging Technologies

General Counsel

• Provide pragmatic, solution-oriented legal advice to support business objectives while managing legal risks
• Draft, review, and negotiate a wide range of domestic and international commercial contracts (Sales, Purchasing, NDAs, Service, IT contracts)
• Provide legal support for research projects, including drafting and reviewing R&D agreements and collaboration contracts with universities and industry partners both domestically and internationally
• Handle routine corporate law matters and prepare related documentation (e.g., shareholders’ resolutions)
• Actively contribute to the design, implementation, and operation of the company-wide Compliance Management System
• Occasionally interact and correspond with domestic and foreign public authorities on legal and compliance matters
• Provide legal advice and support to key departments, particularly Sales, Purchasing, Finance, HR, and R&D, with an emphasis on the company’s international legal context

Junior Legal Counsel

Technical Project Manager

• Act as a key member of the clinical program
• Steer the development of our clinical polarizer and its consumables in close collaboration with internal teams (R&D, Pharma Affairs, QM) and external partners (CDMOs)
• Lead cross-functional project teams to develop products or components being part of the hyperpolarization technology serving the needs of our customers
• Support the evaluation of new projects and the definition of project scope and goals in alignment with key stakeholders to allow achievement of program and business goals
• Plan, coordinate, monitor and manage assigned projects to safeguard their quality and progress within time and budget from initiation through delivery
• Ensure that development activities and deliverables meet applicable requirements and timelines to support submissions and clinical studies
• Forward-looking identification and assessment of project risks and definition of mitigation/ contingency strategies
• Drive collaboration, effective communication and transparency within working groups and project core teams as well as with other involved stakeholders
• Act as single point of contact for external partners (subcontractors, consultants, development partners) and foster sustainable relationships
• Support the Head of Program Management in defining, implementing and living project management best practices and methodologies across the company
• Support the development and implementation of processes, services or tools supporting the successful delivery of systems and consumables

Manager

• As a Validation Manager (m/f/d), you will play a key role in advancing our innovative drug development program
• You will take ownership of all validation activities in the development of our products
• Working closely with multidisciplinary teams and external partners, you will ensure our processes and products meet the highest standards of quality, safety, and regulatory compliance
• Reporting to the Senior Director of Quality, the Validation Manager will have responsibility to develop and manage all validation activities under the Quality Management System
• Provide expert advice on the validation strategy for development programs
• Develop and maintain the Validation Master Plan (VMP)
• Develop systems, processes, tools and templates for the conduct of qualification and validation activities
• Work cross functionally to develop qualification and validation protocols in accordance with the requirements of the VMP
• Review and approve qualification and validation reports
• Project Management of validation activities
• Initiate and manage deviations, changes and risk assessments in the conduct of validation activities
• Quality oversight of the stability program
• Quality oversight and support for technical transfer activities
• Support the ongoing continuous improvement of the company’s QMS in compliance with applicable GxP requirements and regulatory guidelines
• Leading Quality Excellence: Lead by example in promoting and facilitating a quality culture
• 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
• Provide training to staff on quality topics
• Support the conduct of quality investigations and initiatives
• Prepare, manage and present materials for Quality Management Review

Validation Manager, Pharmatech Industry

• Take ownership of product development from analytical method development and validation to drug substance and drug product manufacturing process optimization
• Lead process development activities including manufacturing process optimisation, material qualification, and compatibility testing internally and with contractors
• Develop and manage validation of analytical methods for identity, purity, and impurities using UV–Vis, NMR, HPLC, GC, and Raman internally or with contractors
• Design stability studies and impurity profiling to ensure processes are reliable and fit for purpose
• Drive drug product development activities including formulation and sterile process design
• Coordinate interactions with third-party CDMOs to support outsourced activities
• Support scale-up and technology transfer to clinical manufacturing sites
• Prepare and review CMC documentation, including experimental reports, protocols, SOPs, and eCTD sections
• Work across development, quality, regulatory, and supply chain teams to keep projects aligned and on track

Junior Legal Counsel

Technical Project Manager

Validation Manager, Pharmatech Industry

CMC Development Manager