Configuration Engineer (SAP QM), Quality Operations

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.

Novocure Poland is our newest office in Europe and you will be part of a global business services team supporting multiple business functions including finance and payroll and located in Krakow. The global business services organization within Novocure Poland is critical to Novocure’s efforts to drive process efficiency, standardizations and drive greater business value as the company prepares for future growth.

To support our team in Krakow, Poland we are looking for a:

Configuration Engineer (SAP QM), Quality Operations

In this role as Change and Configuration Engineer, Quality Operations you will support Novocure’s global quality system activities in the areas of change management, change implementation, document distribution / retention integrity and SAP master data changes in the quality Module. This includes providing process oversight and acting as a process expert to provide consistent, reliable support to global business partners with focuses on cycle times and accuracy.

Your responsibilities:

• Perform change control activities in Novocure systems including, but not limited to, SAP Master Data and Mastercontrol.

• Create, maintain, and retire e-Route Cards in SAP S4 Hana in support of Quality Control, Service, and Operations in global Operating Centers

• Assures locally procured and distributed materials for individual Operating Centers are subject to appropriate specification and document control

• Designs and implements new processes and process improvements, particularly in relation to change management and SAP QM/eRoute Card

• Participates in internal audits and regulatory authority inspections, as required

• Participate in Corrective and Preventive Actions (CAPA), as required

• Reviews and provides input into operational QA strategies, and executes for results. Ensures approaches are innovative, industry leading, and meeting the needs of Novocure patients and related Enterprise business strategies

• Works with the Change and Configuration Manager, the QA team, and the IT team organization to deliver against strategic goals and improvement plans

Your profile:

• At least 2+ year experience in SAP/QM

• Demonstrated experience writing, evaluating and improving process procedures

• Proven ability to manage projects and influence teams of significant scope and complexity, while

• meeting all deliverables and timelines

• Outstanding written and oral communication skills in English

• Familiarity with Change Control and Quality Risk Management and process validation

• Familiarity with Quality System Regulation, Medical Device Directive / Medical Device Regulation, ISO 13485 / FDA is a plus

Benefits:

Financial

• Performance related bonus

• Life Insurance

Lifestyle

• Free fruit & cookies delivered for office staff

• Multisport card

Health

• Private Medical care

We are looking forward to receive your application to Natalia Kochanowicz, Talent Acquisition Partner through our Applicant Portal. Please find more information about Novocure and our therapy on our website www.novocure.com or by consulting our patient testimonial videos.