Quality Systems Specialist (Pharmatech Industry) (m/f/d)

Your mission We are searching for a Quality Systems Specialist (m/f/d) to support the establishment and management of an innovative pharmaceutical Quality Management System (QMS). Key Responsibilities: Reporting to the Senior Director of Quality, you will: • Coordinate and manage the daily operation of the QMS in compliance with GxP, regulatory, and internal standards. • Implement and manage a system of QMS metrics and measures • Serve as the principal point of contact for all QMS-related matters. • Support the development, implementation, and continuous improvement of the QMS, ensuring alignment with applicable regulations. • Oversee and coordinate core quality processes, including Document & Training Management, Supplier & Audit Management, Change Controls, Deviations, CAPAs, Self-Inspections, Complaints, and Risk Management. • Apply a risk-based approach and maintain the Quality Risk Register. • Prepare, review, and maintain quality policies, SOPs, and related documentation. • Support the rollout and training of the QMS and the implementation of an eQMS (including system administration). • Conduct self-inspections and ensure continuous improvement initiatives are embedded. • Support and foster a strong Quality Culture: • Provide cross-functional quality support in the design and implementation of processes as part of the QMS • Deliver training and guidance on quality topics. • Support quality investigations and Quality Management Reviews. • Represent Quality in projects impacting the QMS. Your profile • At least 3 years of hands-on experience in quality assurance in a GMP environment. • Demonstrated experience in the development and continuous improvement of cGMP quality systems. • Excellent problem-solving, analytical, and communication skills. • Familiarity with electronic Quality Management Systems (eQMS). • Fluent in English. Why us? • 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 contact information 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 Apply for this job About us 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. _ Please note that, for data privacy reasons, we'll not review applications or arenaflex sent via email. Unsolicited applications can be submitted here. Apply tot his job Apply tot his job Apply To this Job