IQVIA · 1 day ago
QA Auditor
Durham, NC
Full-time
Onsite
Mid Level
$54K/yr - $135K/yr
3+ years expIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. The QA Auditor role involves providing global regulatory oversight of validation management as part of the Quality Management System, including auditing and ensuring compliance with GxP regulations.
AnalyticsHealth CareLife Science
Responsibilities
Plan, schedule, conduct, report, and close Clinical Trial Laboratory Technology Systems Audit activities in IQVIA globally, or its affiliates, to assess compliance with applicable GXP regulations/ GAMP (Good Automated Manufacturing Practices) guidelines, customer requirements, IQVIA SOPs and project specific guidelines/instructions. Thorough auditing evaluates the proper implementation of Software Development Lifecycle (SDLC) methods as they relate to Computer Systems Validation (CSV), IT Quality Systems, and Technology in general
Evaluate audit findings and prepare and distribute reports to operations staff and management and ensure associated corrective/preventive actions (CAPA) are followed up on and implemented
Manage/oversee quality events updates in the electronic quality management system (eQMS) and/or maintain the eQMS and provide support in relation to the audit lifecycle
Perform independent compliance review of pre-validation deliverables and post-validation documentation
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 similar QA activities
Keep current with regulatory developments, including GxP, 21 CFR Part-11, EU Annex 11, GAMP, ICH, risk management, corporate policies and procedures, etc. to ensure IQVIA meets or exceeds industry’s best practices for compliance and validation
Collaborate with other IT members, QA, and 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
Qualification
Required
Bachelor's Degree
3+ years of Quality Assurance experience
Experience with QLIMS, ULTRA, Chromeleon, Spectrophotometer, Top CAT, and ABI Sequencers
GXP experience
Or equivalent combination of education, training and experience
Experience Hosting Client or 3rd Party On-Site Audits and Conducting Internal Audits of various Clinical Trial Quality Sub Systems, including managing organizational responses to client or 3rd party audit reports
Experience working in auditing and compliance of Computer Systems within an FDA regulated environment, such as Clinical Trials, 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
Expert knowledge of Computer Systems Validation (CSV) 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, biotech or medical device required
Knowledgeable in 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
Comprehends GxP computerized systems documentation such as validation plans, requirements and specifications, risk and gap assessments, test plans, qualification protocols, phase reports and summary reports
3-6 years of experience in CRO, Pharmaceutical, Biotechnology, Technical, or related area
Skilled at PowerPoint, Excel, Project Management and other similar tools
Effective organization, communication, and team orientation skills
Ability to manage multiple ongoing projects and deadlines
Excellent written and oral communication skills
Strong level of detail, problem solving, and organizational skills
Strong training capabilities
Ability to initiate assigned tasks and to work independently
Benefits
Incentive plans
Bonuses
Health and welfare and/or other benefits
Company
IQVIA
IQVIA provides analytics, compliance, and management solutions to the life sciences industry.
10001+ employees
H1B Sponsorship
IQVIA has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (167)
2024 (294)
2023 (261)
2022 (229)
2021 (208)
2020 (180)
Funding
Current Stage
Public CompanyTotal Funding
$3.5B2025-06-02Post Ipo Debt· $2B
2023-11-14Post Ipo Debt· $500M
2023-05-18Post Ipo Debt· $1B
Leadership Team
Chris Colapietro
Vice President, Customer Engagement
Jonathan Morris
VP & GM US Healthcare
Recent News
Sabin Vaccine Institute
2025-12-04
Company data provided by crunchbase