This function will support quality oversights of the clinical activities, interacting with the department team members, with internal stakeholders and the external parties, to guarantee compliance to the different regulations in conducting clinical activities where Novocure acts as Clinical Trial Sponsor.

The role of this position also includes management and conduct of QA audits of clinical trials, including but not limited to investigator site audits, audits of Novocure vendors, internal Operational audits in order to assure compliance with Novocure SOPs, Clinical Investigation Plans and referenced regulations and guidelines.

Your responsibilities:

• Conducts Audits to clinical vendors and investigational sites
• Coordinates the activities of Clinical Quality Co-Auditors
• Ensures that audit results are appropriately recorded, reported and communicated and that corrective/preventive actions are properly completed and documented in a timely manner.
• Follows-up on activities to address outcome of conducted audits until their resolution
• Manages and maintains databases for the Quality System
• Supports annual audit plan preparation with a risk-based approach
• Participates and supports different inspection activities (Pre-Approval/routine inspection preparation, inspection anticipation, support and host) and ensures their timely and consistent communication
• Leads and supports Quality improvement projects and initiatives
• Supports Internal Audit Activities as needed
• Evaluates / manages quality issues, CAPAs, and ensures their consistent escalation and communication.
• Prepares and presents the Quality Reviews and Lesson Learnt for the clinical projects based on the audits and inspections’ outcomes and issues and CAPAs, on a risk-based approach
• Supports training activities to increase Quality Awareness and Inspection Readiness in relation to clinical activities
• Ensures activities comply with the applicable Novocure Quality System requirements
• Ensures all duties and responsibilities are fulfilled in line with the established timelines.

Your profile:

• Previous experience in Clinical Quality Assurance, Clinical experience in a Pharmaceutical setting, preferable in a medical device regulated environment

• Proven auditing experience
• Experience with Regulatory Inspections
• Working knowledge of ICH-E6(R2), ISO 14155:2020
• Excellent written and oral communications
• Ability to work in a fast-paced and changing environment; flexible and quickly adaptable to change priorities
• Willingness to work in an international environment and travel around 60% of time (international and domestic)