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 Poland we are looking for an:

Clinical Quality Associate

In this role, you will become the primary point of contact for our clinical operations team for all quality related issues. Implementing clinical quality assurance oversight and integrating clinical operations into Novocure’s quality system. As a clinical quality associate, you provide consultancy and training to stakeholders and work on the continuous improvement of our quality system, contributing strongly to Novocure’s future success.

Your responsibilities:

• Act as Clinical Quality Assurance key contact to Clinical Operations and supports clinical studies and  internal stakeholders,
• Support and manage Inspection preparation activities and ensure their timely and consistent reporting and communication
• Provide GCP advice and support to Clinical Development, Clinical Operations, Clinical Safety, Clinical Supply Chain
• Assist with the development of quality assurance procedures (SOPs, WIs)
• Assist and review of Clinical Development, Clinical Operations procedures
• Assist in development of Novocure´s Quality Management System – focusing on incorporating Clinical operations processes into QMS
• Stay up to date with Clinical Trial Regulation, Medical Device Regulation, ICH GCP and guidelines from other regulatory agencies
• Deliver training to key stakeholders on current regulation, ICH GCP guidelines, ISO standards applicable to clinical investigation contribute to the review of Novocure systems and procedures
• Manage of quality compliance issues, CAPAs, and complaints and their consistent communication
• Support cross-functional quality initiatives or strategic action plans and ensures the project milestones are met and deliverables are provided according to the plan.
• Support the development and implementation of Quality Risk Management processes and methods in clinical domain.

Requirements:

• Scientific Degree in a Medical, Pharmaceutical, Biotechnological/Technical/Scientific field, or equivalent
• Advanced experience of medical device or drug development with extended experience in clinical development, quality management and inspection readiness

• Experience with regulatory inspections
• Knowledge of regulations for Medical Devices such as EN ISO 14155, ICH-GCP
• Fluent in English and preferably German, both written and spoken; any further languages are of benefit
• Highly organized and detail-oriented.
• Excellent written and oral communications, analytical skills, negotiation and interpersonal skills.

Benefits:

Financial

• Performance related bonus
• Life Insurance

Lifestyle

• Free fruit & cookies delivered for office staff
• Multisport card

Health

• Private Medical care