• 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.

• At least 5 years of hands-on experience of validation in a GMP sterile manufacturing environment, ideally in a development setting.
• Strong understanding of and experience of GMP requirements in the EU and US and sound knowledge of applicable ICH guidelines.
• Demonstrated expertise in the management of validation activities.
• Experience of method validation, process validation and equipment qualification.
• Experience of Computer System validation is an advantage.
• Excellent problem-solving, analytical, and communication skills.
• Familiarity with electronic Quality Management Systems (eQMS).
• Fluent in English.

• Competitive compensation, based on base salary and stock options
• Hybrid working model
• 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

Join us in making a difference! Submit your application to be considered for this exciting opportunity.

Any questions? Please contact:
Sandra Schärli
Senior 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 research or clinical environment to produce hyperpolarized contrast agents on demand in a fast, fully-automated, multi-step chemical process. Key steps of the process contain fluidic transport across multiple vessels and chemical mixing and separation processes in fully-reuseable or single-use 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 in-house.

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

_