Senior IT Auditor, Clinical Research

Summary:

The IQVIA QA team is a dynamic, talented, and experienced global team that owns the global quality management system for the largest human data science company in the world. The QA function is responsible for driving compliance in a highly regulated industry through audits, functional support, issue & CAPA management, regulatory consultancy, management of data analytics and customer relationship interactions. These services ensure our clinical research activities are of the highest quality.  We proactively support our business partners and help to drive innovation.  Continuous improvement is a core capability and we value strategic thinking, creativity and operational excellence.  We seek highly motivated people who truly want to make a difference in the life sciences industry and are looking for opportunities to impact the business and be part of the solution. At IQVIA, we support our colleagues with a focus on succession planning, career progression and continuous learning.

Purpose:
As an IT Auditor you will Plan and conduct independent audits to assess compliance with regulations, guidelines, and operating procedures. Prepare and distribute reports of findings to supervisor, operations staff, management, and customers. Provide consultation in interpretation of regulations, guidelines, policies, and procedures. Support management in promotion and assessment of compliance to regulations, guidelines, and corporate policies.

Summary of Responsibilities:

• Collaborates with Quality counterparts at customers and with internal project teams to promote, support and facilitate proactive quality through the identification and management of risks and implementation of quality improvement activities.
• 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
•  Manage Quality Issues
•  Present educational programs and provide guidance to operational staff on compliance procedures
• Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans and track till closures for quality events arising from Quality Issues, Audits, Inspections or during similar QA activities
•  Provide quality assurance consultancy activities and projects for clients within budget and established timelines
• Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements
• Host audits/inspections, ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections
• May perform GLP Archivist duties where needed
•  Manage/oversee quality events updates in eQMS and/or 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

Required Knowledge, Skills and abilities:

• Experience with CAPA and Root Cause Analysis methodologies
• A thorough understanding of GCP and associated regulations in GxP
• A thorough understanding of regulations and guidance (FDA, EU Directives, ICH E6 (R2)) targeting electronic records/electronic signatures as applied to information technology and computerized systems used in clinical trials
• Familiarity with ePRO and eConsent technology
• Familiarity with cloud-based solutions
• Excellent understanding of various Software/System Development Life Cycle models (Waterfall, Rapid Prototyping/AGILE)
• An in depth understanding of the Quality Control (QC), Quality Assurance (QA) and Quality Management (QM) disciplines
• In depth understanding of Computer System Validation of Enterprise level