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Job Details

Quality Assurance Auditor/Senior QA Auditor- Clinical Oversight Program (Italy)

Company: Worldwide Clinical Trials
Reference: VN220
Closing Date: 01 Sep 17
Type: Full Time
Salary (£): Negotiable

Job Summary:

This individual is responsible for the QA Clinical Oversight Program and Audits that are conducted in Italy and other EU countries as necessary.


SUMMARY: Responsible for the QA representation on Clinical Oversight Program in Worldwide’s Italian office located in Rome.
This individual is responsible for the QA Clinical Oversight Program and Audits that are conducted in Italy and other EU countries as necessary.


• This individual reports directly to the Sr. Director of the QA Clinical Oversight Program 
• Performs various types of clinical audits in accordance with the Annual QA Audit Plan
• Serves as the QA Therapeutic Representative
• Provides guidance and support to the  Clinical Operational Teams as assigned and specifically in Italy
• Provides guidance and oversight of Corrective and Preventive Actions that are triggered by Audit observations, quality issues or inspectional findings
• Executes against the Worldwide Quality Management System
• Ensures document management in accordance with the Quality Management System
• Participates in SOP reviews as relevant to the Auditing Program and training program in Italy
• Supports AIFA inspections in Italy and other Supports Regulatory inspections and Worldwide Audits as assigned
• Generates quality metrics for senior QA management on Italian clinical programs
• Perform other duties as assigned.  The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive

• Serves as an individual contributor
• Demonstrated ability to conduct various types of GCP audits inclusive of Clinical Investigator Audits, Trial Master File Audits, Clinical Study Report Audits, Vendor Audits, Marketing Application Audits, and Database Audits)
• Communications professionally, concisely, clearly and consistently to internal and external customers both verbally and in writing
• Self-motivated and ability to work independently or in a team
• Demonstrated skills for influencing, being resourceful, managing conflict and negotiating
• Ability to speak, read and write in English and Italian fluently
• Works with a sense of urgency; ability to recognize time sensitivity and leads assertively
• Strong understanding of clinical research principles and the drug development lifecycle
• Demonstrated ability to work collaboratively with cross functional stakeholders to drive process improvements based on Quality Indicators

• Working knowledge of ICH Guidelines, FDA regulations, European Directives, MHRA Statutory Instruments
• Must have an excellent understanding of the AIFA Decree
• Good understanding of the Drug Development Process
• M.S. in a scientific or allied health filed and  2+ years of relevant GCP, GLP, GVP experience
• Four-year college curriculum with concentration in biological, physical, health, pharmacy or other related science and 4+ years of relevant GCP, GLP, GVP experience
• Domestic and international travel required (approximately 30%)

Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently. #L1-HD1

Apply for this job: Quality Assurance Auditor/Senior QA Auditor- Clinical Oversight Program (Italy)

Contact Information:

Address:  Worldwide Clinical Trials
2nd Floor 172 Tottenham Court Road London
Tel:  0207 121 61 61
Website:  Visit Our Web Site

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