Job Description

Job Profile Summary

This Sr QA Auditor will work with IQVIAs wholly owned subsidiary and laboratory division, Q2 Lab Solutions. Q2 Solutions is a leading global clinical trial laboratory services organization providing comprehensive testing, project management, supply chain, biorepository and specimen management, and clinical trial sample and consent tracking solutions.

Essential Functions

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.

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 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.

May assist in the training of new Quality Assurance staff and provide guidance to operational staff on compliance procedures.

Represents the Technology QA Team at Audits and Client Meetings when necessary

Requirements:

Bachelor\xe2\x80\x99s Degree

5+ years of experience in CRO, Pharmaceutical, Biotechnology, Technical, or related area

3+ years of 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 \xe2\x80\x93 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.

Skills and Abilities

Skilled at PowerPoint, Excel, Project Management and other similar tools. Experience with SharePoint and Trackwise is a plus.

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.

Location & Travel:

Hybrid Opportunity

On-site at least 3 days a week at Q2 Solutions in Durham, NC

May need to travel as needed to remote labs in Austin, TX / Valencia, CA / Seattle, WA

Quality Assurance Department:

The IQVIA Enterprise 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.

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 \xe2\x80\x93 to help our customers create a healthier world. Learn more at

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities.

As the COVID-19 virus continues to evolve, IQVIA\xe2\x80\x99s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status.

IQVIA