Job Description

JOB DESCRIPTION Essential Functions . Plan, schedule, conduct, report and close System audit activities in IQVIA global or its affiliates to assess compliance with applicable GXP regulations/GAMP guidelines, customer requirements, IQVIA SOPs and project specific guidelines/instructions. Through auditing evaluates the proper implementation of SDLC methods as they relate to Computer Systems Validation, IT Quality Systems, and Technology in general. . Evaluate audit findings and prepare and distribute reports to operations staff, management, and ensures associated corrective/preventive actionsare followed-up on and implemented. . 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 . Manage Quality Issues, 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 simillar QA activities . Keep current with regulatory developments, including GxP, 21 CFR Part 11, EU Annex 11, GAMP, ICH, and risk management, corporate policies and procedures, etc. to ensure IQVIA meets or exceeds industry best practices for compliance and validation. . Collaborates with other IT members, QA, & business functions on validation of new systems and improvement of existing IT Quality processes/practices. . Provide consistent interpretation and implementation of regulatory controls to project teams on regulations, guidelines, compliance status, and policies and procedures . Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements . Lead/collaborate/support in QA initiatives/projects for quality, process improvements .Assist in training of new Quality Assurance staff and educational programs and provide guidance to operational staff on compliance procedures . Represents the Technology QA Team at audits/client meetings when necessary What makes you a great fit: year\'s experience working in auditing and compliance of computer systems within an FDA regulated environment, or within a SaaS provider whose products target FDA regulated companies and whose products must be able to be validated to be compliant with 21CFR Part 11. Comprehends documents supporting GxP computerized systems, and relevant infrastructure, including validation plans, requirements and specifications, risk and gap assessments, test plans, qualification protocols, phase reports and summary reports. Expert knowledge of Computer Systems Validation in a life science or regulated environment required. Experience with software validation and testing methodologies, documentation and product specifications in an FDA regulated environment such as pharmaceutical, bio-tech or medical device required. Knowledgeable in all of the following regulations/regulatory guidelines: 21 CFR Part 11, Electronic Records - Electronic Signatures General Principles of Software Validation - Final Guidance for Industry and FDA Staff Good Automated Manufacturing Practices (GAMP) guidelines or other methodologies for Computer Systems Validation in a regulated environment and Data Integrity requirements. BA/BS degree in a technical field, or equivalent education and experience. Minimum of 5 years experience hosting client or 3rd party on-site audits and conducting internal audits of various quality sub systems required, including managing organizational responses to client or 3rd party audit reports. Skilled at Microsoft Word, Powerpoint, Excel, Project management other similar tools. Experience with Sharepoint and Trackwise is a plus. Ability to manage multiple ongoing projects and deadlines. Excellent written and oral communication skills. Strong level of detail, problem solving, and organizational skills. IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at

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