Clinical Quality Auditor

JOB SUMMARY:

 

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

This is a full-time, exempt position located in our Portsmouth, NH or Chesterbrook PA office reporting to the Audit Manager, Clinical Quality Assurance.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Conducting Audits to clinical vendors and investigational sites located in the North America region
• Coordinating the activities of Clinical Quality Co-Auditors
• Following up on activities to address outcome of conducted audits until their resolution.
• Performing internal escalation as needed based on results of audit activities
• Providing reports on clinical audit activities
• Supporting Novocure inspection readiness and compliance
• Providing support in definition of requirements for quality improvement initiatives
• Supporting Novocure Quality System Compliance and Inspection Readiness administrative activities
• Providing support as requested during third parties audits or inspections happening at investigational sites or clinical vendors
• Ensure activities comply with the applicable Novocure Quality System requirements
• Active participation in quality improvement projects as defined by the manager
• To fulfill all duties and responsibilities in line with the established timelines.
• In time delivery regarding assigned tasks and project deliverables
• Monthly travel required to perform audits at our clinical sites

 

QUALIFICATIONS/KNOWLEDGE:

• Qualifications:
  • Master Degree or equivalent in a scientific discipline or related field
  • Lead Auditor certification for external quality audits, preferably in the Good Clinical Practices (GCP) audits
• Experience:
  • At least 15 years of total working experience
  • At least 6 years of work experience in the Medical Device or Pharma Industry
  • At least 4 years of work experience in the Clinical investigation field in the Medical Device or Pharma Industry
  • At least 2 years of quality auditing practice in the Medical Device or Pharma Industry

• Skills:              
  • Excellent written and oral communication skills
  • Fluent in English
  • Proficient in Microsoft Office
  • Able to work in a team environment and execute tasks with minimal direct supervision
  • High degree of attention to details and general culture of quality
  • Working knowledge of ICH-E6(R2), ISO 14155:2020