Associate Quality Assurance Director (R1085778) - Durham, NC - IQVIA™

Date de publication 10/4/2019

Résumé de l'offre

  • Type d'employé
    CDI / CNE
  • Expérience
    Not Specified
  • Date de publication
    10/4/2019
  • Job ID:
    R1085778

Description de l'offre

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.

Associate Quality Assurance Director, eCOA

The eCOA (electronic clinical outcomes assessment) division of IQVIA enables pharmaceutical companies and clinical research organizations to build and deploy their own subject data collection solution, allowing clinical outcomes assessments to be used in more studies. Whether deploying to smartphones, tablets or the web, our build and deployment tools help automate the eCOA process, giving absolute transparency and greater control to sponsors and CRO’s. 

Responsibilities to include:

  • Assist in establishment of quality assurance and control policy by providing consultation and recommendations to regional and Global QA Management.
  • Serve as author for QA SOPs and may act as regional QA representative to the Global QA SOP taskforce.
  • Support quality management in proposal reviews and reporting QA metrics.
  • Conduct trend analysis of audit results and provide QA Management with initial root cause analysis.
  • Ensure proper coordination of customer-initiated audits and mock regulatory inspections and manage regulatory facility inspections.
  • Direct and / or participate in the scheduling, preparation for, Conduct, reporting, and close out for all audits assigned.   This may include, but is not limited to, internal, external, client and vendor audits.
  • participate in review and closure of corrective actions, as required.
  • Act as a resource for information, consultation and training concerning applicable regulations, guidelines and quality issues to study teams, working groups, and task forces for assigned projects.
  • Act as a resource to the department by providing guidance, interpretation, training and key input regarding operating procedures and processes.
  • Facilitate the Conduct of customer-initiated audits, mock regulatory inspections, and assists in regulatory facility inspections, as applicable.  may host customer audits and works with responsible parties to prepare corrective action plans.
  • Maintain working knowledge of current applicable regulatory regulations and guidelines and related auditing techniques.
  • Oversee the documentation and reporting quality/compliance issues, relating to the product, process or quality system, to Management within specified regional timelines.  Collect and report quality metrics as required to quality Management.
  • Assists in conducting training seminars on quality issues and SOP development.
  • Works with Global counterparts to Ensure Global standardization within the departments.

Minimum Education, Experience, & Specialized Knowledge Required:

  • Bachelor’s degree or equivalent and six (6) eight (8) years relevant experience. 
  • Pharmaceutical industry experience strongly preferred.
  • One (1) to two (2) years of experience using IQVIA data and products, strongly preferred.
  • Strong presentation skills required.
  • Experience with the MS Office Suite

Join Us

Making 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/Disabled

IQVIA, 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.



Job ID: R1085778