Job Description

Work From Home - Remote Opportunity - US and Canada

Purpose:

This Sr QA Auditor is responsible planning and conducting independent Clinical Trial Investigator Site Audits in the Americas and Global Internal 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:

Plan, schedule, conduct, report and close any type of GCP audits (e.g., investigator site, eTMF, database, vendor audits, process audits) conducted on-site or remotely.

Conduct audits 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.

For each audit, deliver an audit report and review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans.

Verify completion of the CAPAs as agreed in IQVIA electronic Quality Management System (eQMS).

Conduct joint audit with junior auditors or experienced auditors for training, coaching, and/or more complex audits as needed.

Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures

Provide consultation to project teams and auditees in interpretation of audit observations and formulation of corrective action plans

Present educational programs and provide guidance to operational staff on compliance procedures

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

May be asked to host/co-host audits/inspections as needed.

Contribute to the development of innovative audit strategy and audit tools.

Required Education and Experience:

5+ years of experience in a pharmaceutical, biotech, CRO, or other regulated area

3+ years experience in GCP Quality Assurance

Bachelor\xe2\x80\x99s degree in a scientific or healthcare-related field

Or equivalent combination of education, training and experience.

Demonstrated experienced in the conduct and reporting of GCP Audits for Phase I to Phase IV studies (e.g., investigator sites, eTMF, database, Clinical Study Report, process, third-party vendor)

Required Knowledge, Skills and Abilities:

Knowledge and experience working with ICH-GCP guidelines

Knowledge of Word-processing, spreadsheet, and database applications.

Extensive knowledge of pharmaceutical research and development processes and regulatory environment

Knowledge of quality assurance processes and procedures

Strong interpersonal skills

Excellent problem solving, risk analysis and negotiation skills.

Strong training capabilities.

Effective organization, communication, and team orientation skills.

Excellent team players

Ability to initiate assigned tasks and to work independently.

Ability to manage multiple projects.

Ability to establish and maintain effective working relationships with coworkers, managers, and customers.

Travel Requirement:

The workplace is remote, and the Global Internal Audits are remote.

1-2 Investigator Site Audits will be conducted per month, primarily in the Americas. You will be on site for 2-3 days at a time.

Summary:

The IQVIA Quality Assurance 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, hosting customer audit and regulatory inspections, 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.

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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

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