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QA Manager / Associate QA Director QA Stakeholder Engagement Lead SEL - Clinical - 1720371

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Durham, NC

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Job Description
Join us on our exciting journey!IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.DescriptionLet your career soar within Clinical QA!  We have an exciting opportunity for a QA Manager / Associate QA Director within our QA Stakeholder Engagement Lead (SEL). \r \rThe QA Manager / Associate QA Director will provide support to management in the promotion and assessment of compliance with regulations, guidelines, and operating procedures. Manage QA oversight of projects, assignments, and training. Conduct independent audits to assess compliance with regulations, guidelines, and operating procedures. Prepare and distribute reports of findings to operations staff, management, and customers. Provide consultation in interpretation of regulations, guidelines, policies, and procedures. \r\r
 \rRESPONSIBILITIES:\r\rPlan, schedule, conduct, report and close audit activities in any of the countries involved with Quintiles contracts. Audits are conducted to assess compliance with applicable regulations/guidelines, customer requirements, IQVIA SOPs and project specific guidelines/instructions. \rEvaluate audit findings and prepare and distribute reports to operations staff, management, and customers. \rProvide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures. \rProvide consultation to customers, functional leads and monitors in interpretation of audit observations and formulation of corrective action plans. \rPrepare, review and approve corrective action plans \rPresent educational programs and provide guidance to operational staff on compliance procedures. \rConduct quality assurance consultancy activities and projects for clients within budget and established timelines. \rEvaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements. \rHost customer audits \rHost mock regulatory inspections and regulatory facility inspections\rProvide training for new Quality Assurance staff\rServe as author of Quality Assurance SOPs as assigned \rAdvise Quality Assurance management on system audit needs\rAct as regional or Global QA Coordinator for assigned customers projects\rOversee documentation, reporting, and closure of compliance issues \rLead Projects\rTrain new auditors and staff as required\r \r \r

Job Requirements
Bachelor’s/primary degree and 7 - 10 years Quality Assurance experience in pharmaceutical, technical, or related area; or equivalent combination of education, training and experience; or equivalent combination of education, training and experience.\r \r\rKnowledge of word-processing, spreadsheet, and database applications. \rExtensive knowledge of pharmaceutical research and development processes and regulatory environments. \rConsiderable knowledge of quality assurance processes and procedures. \rStrong interpersonal skills. \rExcellent problem solving, risk analysis and negotiation skills. \rExceptional training capabilities. \rEffective organization, communication, team orientation, and leadership skills. \rAbility to work independently with initiative. \rAbility to manage multiple projects. \rAbility to establish and maintain effective working relationships with coworkers, managers and clients\rPosition requires a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time.\rPosition requires extensive use of telephone and face-to-face communications, which requires the accurate perception of speech.\rOccasional travel. \r \rEEO Minorities/Females/Protected Veterans/Disabled

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Company Profile
Healthcare is an industry designed to help humans. As a global community, we continuously invest and commit to advancing human health. To deliver value and real outcomes. To rise to the challenge to find the next breakthrough by making the most of increasingly limited resources. We are inspired by the potential and propelled by the possibilities. We share the vision to drive healthcare forward. To see how we can help accelerate progress and achievements. Others are developing these medical breakthroughs. We do our part by using breakthroughs in insights, technology and human intelligence to reimagine and deliver ways to help make them a reality. It’s bigger than better clinical trials. Or advances in technologies and analytics. Or faster insights. It’s about exploring a new path to better health outcomes via Human Data Science. It’s about harnessing the power of the IQVIA CORE™ to channel the insights, commercial and scientific depth, and executional expertise that drive maximum value for our customers. Motivated by the industry we help, we’re committed to providing solutions that enable life sciences companies to innovate with confidence, maximize opportunities, and, ultimately, drive human health outcomes forward.

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