Senior IT Auditor - Clinical Research Compliance

Senior IT Auditor, Clinical Research

Job Description Summary – Senior IT Auditor

Location: Bengaluru (Hybrid) | Global travel up to 20–40% depending on study/vendor portfolio

Job Overview
• Plan and conduct independent technology 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.

Essential Functions
• Plan, schedule, conduct, report and close audit activities across countries to assess compliance with regulations, customer requirements, SOPs, and project guidelines.

Audit Planning & Strategy
• Perform risk assessments on technology vendors; determine audit type, scope, and cadence.

Audit Execution
• Lead qualification, for-cause, and surveillance audits of vendors delivering eClinical solutions, medical information systems, data hosting/analytics, AI/ML tools, DCT components, and GxP-relevant cloud services.
• Evaluate audit findings and prepare reports.
• Provide interpretation on regulations, guidelines, compliance status, policies, and procedures.
• Consult customers and monitors on audit observations and CAPA plans.
• Manage Quality Issues as required.
• Deliver training and guidance on compliance procedures.
• Review and approve investigations, RCA, CAPA, and EC plans; track quality events to closure.
• Evaluate policies for compliance and recommend process improvements.
• Host audits/inspections and support regulatory inspection readiness.
• Maintain eQMS updates and support audit lifecycle activities.
• Lead/support QA improvement initiatives and train new QA staff.

Qualifications
• Bachelor’s degree in Life Sciences, Computer Science, Information Systems.
• 10+ years of experience in pharmaceutical, technical, or related GxP QA/CSV/IT audit roles.
• Strong knowledge of R&D processes, regulatory environments, and SaaS/eClinical vendor auditing.
• Ability to work independently and lead onsite/remote audits internationally.
• Strong interpersonal, problem solving, risk analysis, negotiation, training, and communication skills.

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 https://jobs.iqvia.com

IQVIA 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.

Experience Level

Senior Level