Clinical Quality Auditor

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:

Clinical Quality Assurance Auditor

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)

Benefits:
•    Performance related bonus
•    Life Insurance 
•    Free fruit & cookies delivered for office staff
•    Multisport card 
•    Private Medical care

...and more!

We are looking forward to receive your application to Emilia Bagińska, Senior 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.