Remote Opportunity

Job Overview:

The Quality Assurance Auditor 2 will Host/Conduct/Support Customer Audits and Regulatory Inspections; Conduct and/or support audit report preparation/distribution; Support quality issues management; Responsible for Corrective and Preventative Action (CAPA) and Effectiveness Check (EC) plan review, approval and closure; Provide consultation in interpretation of regulations, guidelines, policies, and procedures; Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies; Lead/support in QA initiatives/projects for quality and process improvements.

Summary of Responsibilities:

• Plan, schedule, host, conduct and close audit activities in any of the countries involved with IQVIA contracts to assess compliance with applicable regulations/guidelines, customer requirements, Standard Operating Procedures ( SOPs) and project specific guidelines/instructions.

• Host audits/inspections and ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections.

• Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers.

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

• Provide consultation to customers and monitors in interpretation of audit observations

• Review and approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans. Track until closures for quality events arising from Customer Hosted Audits, Inspections or during similar QA activities

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

• Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.

• Assist in training of new Quality Assurance staff.

• Support in QA initiatives/projects for quality, process improvements

• Manage/oversee quality events updates in eQMS

• Maintains the electronic quality management system (eQMS) and provides support in relation to the audit lifecycle

Required Education and Experience:

• Bachelor’s degree in a scientific or healthcare-related field

• 3+ years Clinical Quality Assurance experience in a Pharmaceutical, Biotech or CRO Industry

• Or equivalent combination of education, training and experience.

• Experience in GCP and PV, and other GxP, Auditing techniques.

• Demonstrated experience scheduling, planning, conducting and hosting customer audits and regulatory inspections.

• Thorough understanding of requirements of major regulatory agencies (FDA, EMA, PMDA) and demonstrated experience interpreting and applying relevant regulations, laws and guidance.

• Practical experience applying proactive quality approaches for clinical trials.

• Preferred experience in Real Word Data / Real World Evidence

• Tech savvy.

Required Skills and Abilities:

• Ability to work with word-processing, spreadsheet, and database applications.

• Strong interpersonal skills.

• Excellent problem solving skills.

• Effective organization, communication, and team orientation skills.

• 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 clients.

Travel:

• Up to Around 30%; Hosting 1-4 Audits per month; Virtual and On-Site

Department Summary:

The IQVIA 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, 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 – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com