Senior QA Auditor GCP Audits

Overview:

Essential Functions:

• Plan schedule conduct report and close audit activities in any of the countries involved with IQVIA contracts to assess compliance with applicable regulations/guidelines customer requirements IQVIA SOPs and project specific guidelines/instructions
• Evaluate audit findings and prepare and distribute reports to operations staff management and customers
• Provide interpretation and consultation to project teams on regulations guidelines compliance status and policies and procedures
• Provide consultation to customers and monitors in interpretation of audit observations and formulation of corrective action plans
• Review approve investigations Root Cause Analysis (RCA) Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans and track till closure for quality events arising from Audits; and from Quality Issues Inspections or during similar QA activities as assigned.
• Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements
• Maintains the electronic quality management system (eQMS) and provides support in relation to the audit lifecycle
• Lead/collaborate/support in QA initiatives/projects for quality process improvements
• Assist in training of new Quality Assurance staff
• May be required to manage Quality Issues
• May present educational programs and provide guidance to operational staff on compliance procedures
• May perform pre-inspection visits at sites host audits/inspections; ensure proper conduct of customer-initiated audits and mock regulatory inspections and assist in regulatory facility inspections as assigned.

Qualifications:

• Bachelors Degree Pref
• Travel 30-50%
• 5 years experience in pharmaceutical technical or related area of which 3 years in Quality
• Assurance Audits. GCP experience. Equivalent combination of education training and experience.
• Experienced in the conduct of clinical trial Investigator site audits.
• Experience in the conduct of clinical study report/data management/biostatistics clinical trial audits is preferred.
• Knowledge of word-processing spreadsheet and database applications.
• Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
• Knowledge of quality assurance processes and procedures.
• Strong interpersonal skills.
• Excellent problem solving risk analysis and negotiation skills.
• Strong training capabilities.
• Effective organization communication and team orientation skills.
• Ability to initiate assigned tasks and to work independently.
• Ability to manage multiple projects.
• Ability to establish and maintain effective working relationships with coworkers managers and clients.

IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status as a protected veteran or any other status protected by applicable law. is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements misrepresentations or material omissions during the recruitment process will result in immediate disqualification of your application or termination of employment if discovered later in accordance with applicable law. We appreciate your honesty and professionalism.