CAPA Specialist

Novocure is a global publicly-traded commercial-stage oncology company developing a profoundly different cancer treatment therapy called Tumor Treating Fields (TTFields) for patients with solid tumors. TTFields therapy is a non-invasive, novel, antimitotic treatment modality which utilizes proprietary technology attempting to slow or reverse tumor progression by inducing tumor cell death. Novocure's commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma (GBM) in the USA, Europe and Israel. Novocure has ongoing or completed clinical trials and is further expanding its efforts into several other solid tumor indications - non-small cell lung cancer, pancreatic cancer and other types of solid cancers. JOB SUMMARY: We are looking for the CAPA specialist who will participate in the implementation and maintenance of the CAPA process within the Quality Management System, to meet all internal and regulatory requirements. The CAPA specialist works closely with the global CAPA manager and other functional areas to ensure CAPA-related activities and documentation are managed in a complete, clear, concise, and controlled manner. The CAPA specialist will deputize as the CAPA manager and Quality Assurance Engineers and take over relevant activities based on need. This is an exempt, full-time role tied to the Krakow office reporting to the CAPA Manager. This is hybrid position that requires office presence 3 times per week. ESSENTIAL DUTIES AND RESPONSIBILITIES: Supports local and global functions in the management of their CAPAs Coordinates CAPA review meetings, tracks and follows up with action items. Ensures all investigations are written according to the CAPA policies and procedures. Assists in developing CAPA training content and provides CAPA training as required Facilitates the Root Cause Investigation and Action Plan processes Ensures activities comply with Novocure Quality System requirements, ISO 13485 and other applicable medical device standards / regulations Monitoring and analyzing Issue / CAPA related quality data and metrics in terms of improvement opportunities As assigned, contributing to updates or creation of Quality System Documents Supporting the line manager as required and advised in the daily business activities Supporting Novocure inspection readiness and compliance activities Supporting quality improvement projects as defined by the manager ln time delivery regarding assigned tasks and responsibilities. Fulfilling duties and responsibilities in line with the Quality Objectives and Goals. Acting in accordance with Novocure's Code of Conduct. QUALIFICATIONS/KNOWLEDGE: Qualifications: Associate Degree in the Engineering, Life Sciences, or related areas Minimum 2 years’ experience in Quality, Manufacturing or Engineering industries in similar position (preferred for medical devices) Knowledge: Familiarity with regulations, standards, and guidance for medical devices (like ISO 13485, MDR and MDSAP) - advantage Ability to solve problems and utilize analytical skills Excellent written and oral communication skills - ability to communicate clearly, accurately and directly to a widely varied audience Excellent organizational and time management skills - ability to prioritize and manage several tasks simultaneously Fluent in English, written and spoken Able to work and collaborate in a team environment and execute tasks with minimal direct supervision High degree of attention to details and general culture of quality Proficient in Microsoft Office OTHER: Willingness to travel (about 10-20%) COMPENSATION: The annual base salary ranges from 142.700 PLN to 174.400 PLN yearly*. This pay range is the range of base pay compensation within which Novocure expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and skills demonstrated. BENEFITS: Performance related bonus Life Insurance Multisport card/Benefit system Private Medical care ..and more! We are looking forward to receive your application to Karolina Zwolak-Grzybek, Senior Talent Acquisition Partner through our Applicant Portal. Please find more information about Novocure and our therapy on our website www.novocure.com