Clinical Quality Auditor

Clinical Quality Auditor

Novocure

Poland

JOB SUMMARY

You 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.

RESPONSIBILITIES

• Conducting audits to clinical vendors and investigational sites
• Coordinating the activities of Clinical Quality Co-Auditors
• Ensuring that audit results are appropriately recorded, reported and communicated, and that corrective/preventive actions are properly completed and documented in a timely manner
• Following-up on activities to address outcome of conducted audits until their resolution
• Managing and maintaining databases for the Quality System
• Supporting annual audit plan preparation with a risk-based approach
• Participating and supporting different inspection activities (Pre-Approval/routine inspection preparation, inspection anticipation, support and host) and ensures their timely and consistent communication
• Leading and supporting Quality improvement projects and initiatives
• Supporting Internal Audit Activities as needed
• Evaluating / managing quality issues, CAPAs, and ensuring their consistent escalation and communication.
• Preparing and presenting 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
• Supporting training activities to increase Quality Awareness and Inspection Readiness in relation to clinical activities

YOUR PROFILE

Qualifications:

• Degree in a Medical, Pharmaceutical, Biotechnological, or related scientific /technical field

Knowledge:

• Profound working experience in Clinical Quality Assurance in a Pharmaceutical or Medical Device regulated environment, or preferably in a medical device regulated environment
• Proven auditing experience with regulatory inspections
• Proficient communication skills in English, both written and verbal. Knowledge of another European language (Spanish, Italian, French, German etc) would be a plus.
• Working knowledge of regulations for Medical Devices such as EN ISO 14155, ICH-GCP would be a plus
• Ability to work independently with minimal supervision and as a member of a team
• Enthusiasm, attention to details, ability to meet aggressive deadlines, and ability to work effectively with others in a fast paced, highly-productive environment
• Willingness to work in an international environment and travel around 30% of time (international and domestic)

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