Principal / Senior QA Auditor

Principal Auditor, Clinical Quality Assurance (CQA) *LI-MB1

Italy or other EU location

Position Summary:

• Perform QA audits of clinical trial data and records in order to assure compliance with ICON or Sponsor SOPs, study protocols, Good Clinical Practice guidelines, relevant regulations and ISO  requirements.
• Assist with the implementation and maintenance of an effective Quality Assurance program within ICON.
• Assist with local project resourcing and the professional development of the QA Auditors.

Principal Auditor Role at ICON:

• Effectively Plan and conduct QA audits in order to assure that clinical studies managed by ICON are of the highest standard and are in compliance with requirements of ICON/Sponsor Standard Operating Procedures, study protocols and relevant regulations.
• Maintain a thorough knowledge of all relevant ICON SOPs, Good Clinical Practice guidelines, relevant regulations and ISO  requirements.
• Perform quality system audits and process audits.
• Perform supplier/vendor audits.
• Perform contract audits for Sponsor companies.
• Ensure that audit results are formally recorded and reported and that corrective/preventative actions are documented.
• Assist with the review of audit reports and audit results, and with performing analyses and trending of audit results, as required.
• Assist with the planning and coordination of specific projects related to the development and Improvement of the ICON Quality Assurance program
• Perform lead auditor duties assigned in an efficient and effective manner. This includes liaising with the project manager on all QA issues, including audit planning and review of audit results.
• Perform QA Review of SOPs, as required.
• Train and mentor new QA auditors in order for them to perform their function effectively and provide a benchmark of auditing competencies to less experienced colleagues.
• Liaise with clients and project managers on quality aspects of studies including the attendance at meetings, oral presentations and audits.
• Assist with business development activities, as required.
• Coordinate or assist with sponsor audits and regulatory Inspectors, as required.
• Assist with the management of the department when requested including local project resourcing, assignment of workload, and scheduling and review of audits. 

To succeed you will need:

• University/Bachelors Degree or local equivalent in medicine, science or equivalent degree/experience
• Extensive experience in Quality Assurance auditing.
• Thorough knowledge of GCP Guidelines and relevant regulations for the conduct of clinical trials.
• Excellent communication and interpersonal skills, including the ability to liaise successfully with project teams, investigators and clients.
• Ability to successfully implement quality plans for all phases of a trial.
• Ability to make and defend pragmatic quality decisions relating to the conduct of clinical trials.
• Good commercial awareness and customer focus.
• Detailed understanding of drug development and clinical trial process.
• Demonstrated training skills, including the ability to give constructive feedback.
• Highly developed problem resolution skills.
• Good planning and organizational skills with the ability to multi-task and prioritize effectively.
• Ability to work efficiently and independently under pressure.
• Cost consciousness.
• Ability and willingness to travel at least 35% of the time (international and domestic) 

Benefits of Working in ICON 

Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package.  This varies from country to country so a dedicated recruiter will discuss this with you at interview stage. We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.   

ICON is an equal opportunity employer -  M/F/D/V and committed to providing a workplace free of any discrimination or harassment.