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Director, QA

Company: IQVIA
Location: Durham
Posted on: September 8, 2020

Job Description:

IQVIA--- is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.Purpose:This position is a QA Director position to lead the Vendor Audit Program who will serve as the strategic head for the vendor qualification audit program for IQVIA.-- The role includes the following activities for the assigned audit program. The QA Director is responsible for serving as a strategic lead to liaise with internal stakeholders and service providers to develop, plan and execute the vendor audit program in compliance with regulatory requirements and industry best practices-- --This position will also be responsible for providing Quality Assurance input into Master Service Agreements and Requests for information (RFIs) from IQVIA customers. This is a highly visible and important position within QA and requires both strategic vision and personal tactical execution. Summary of Responsibilities:Drives all activities associated with the planning and development of the vendor audit program for R&DSCollaborates with internal stakeholders to proactively identify service providers to be assessed and considered in audit planningLeads risk assessment activities to proactively identify potential risks associated with service providers and the resultant audit planning processResponsible to implement vendor audit plans and schedules, working across the organizationEngage in the development and assessment of metrics and dashboards to facilitate the analysis of quality trends to ensure--key targets are assessedIdentify quality improvements in the audit programSupports the management and resolution of significant quality issues observed with service providersInterfaces with senior management to discuss quality and compliance issuesInterfaces with Business Development and Legal to provide Quality Assurance input to Master Services Agreements and RFIsRequired Knowledge, Skills and abilities:Thorough understanding of GCP, PV, and other relevant quality compliance requirements of major regulatory agencies (FDA, EMA, PMDA) and demonstrated experience interpreting and applying relevant regulations, laws and guidance.Practical experience managing large scale vendor audit programs.Strong negotiation and influencing skills; demonstrated ability to work constructively and effectively at all levels across functions as well as with external customers--Superb and polished ability to consistently present information in a clear, compelling, and understandable format, tailoring presentations to the context and audience.----Demonstrable experience and ability to utilize analytics to make data-driven decisions and assess impact of interventions--Required Education and Experience:Bachelors degree in a scientific or healthcare-related fieldDemonstrated experience leading and successfully delivering on high-profile quality initiatives with senior executive leadership visibility.Minimum 5 years of experience in experience in clinical quality in a pharmaceutical, biotech, or other regulated industry.--#LI-NM2#LI-RemoteJoin UsMaking a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.Forge a career with greater purpose, make an impact, and never stop learning.IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/DisabledIQVIA, Inc. provides reasonable accommodations for applicants with disabilities.-- Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA's Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.Full time

Keywords: IQVIA, Durham , Director, QA, Executive , Durham, North Carolina

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