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Job Details

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

Company name
IQVIA.

Location
Durham, NC

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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).

The 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.

RESPONSIBILITIES:

Plan, 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.

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, functional leads and monitors in interpretation of audit observations and formulation of corrective action plans.

Prepare, review and approve corrective action plans

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

Conduct 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.

Host customer audits

Host mock regulatory inspections and regulatory facility inspections

Provide training for new Quality Assurance staff

Serve as author of Quality Assurance SOPs as assigned

Advise Quality Assurance management on system audit needs

Act as regional or Global QA Coordinator for assigned customers projects

Oversee documentation, reporting, and closure of compliance issues

Lead Projects

Train new auditors and staff as required

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.

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

Extensive knowledge of pharmaceutical research and development processes and regulatory environments.

Considerable knowledge of quality assurance processes and procedures.

Strong interpersonal skills.

Excellent problem solving, risk analysis and negotiation skills.

Exceptional training capabilities.

Effective organization, communication, team orientation, and leadership skills.

Ability to work independently with initiative.

Ability to manage multiple projects.

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

Position requires a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time.

Position requires extensive use of telephone and face-to-face communications, which requires the accurate perception of speech.

Occasional travel.

EEO Minorities/Females/Protected Veterans/Disabled

Company info

IQVIA.
Website : https://www.iqvia.com/

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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