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Senior Quality Specialist (R1012312) in Cambridge, MA at IQVIA™

Date Posted: 2/14/2018

Job Snapshot

Job Description

Job Summary

The Senior Quality Specialist is responsible for supporting the maintenance of the corporate Quality Management System (QMS) that promotes customer satisfaction and company improvement. The Senior Quality Specialist initiates and implements quality improvement activities as appropriate to raise performance of the company services. In addition, the Senior Quality Specialist independently carries out QMS improvement and maintenance activities as assigned.

Summary of Essential Job Functions

Responsibilities include:

  • Support maintenance of company Quality Management System
  • Maintaining company Quality Management System (QMS) documents and artifacts.
  • Managing and coordinating internal audits and supporting client audits
  • Supporting client audits
  • Maintaining company-wide quality and SDLC document templates
  • Coordinating QMS training efforts and training others on DrugDev LMS System
  • Building strong relationships with internal clients, providing quality management support
  • Coordinating the company-wide Corrective and Preventive Actions (CAPA) program
  • Facilitating the CAPA process and Investigations
  • Supporting quality management related internal project team meetings and calls
  • Supporting project teams during quality management related sponsor meetings and calls
  • Other duties as assigned


  • Strong interpersonal and communication skills (both written and verbal).
  • Understanding of clinical trials.
  • Knowledge and experience with 21CFR Part 11 and GXP.
  • Self-starter with the ability to work in a global team environment.
  • Ability to carryout quality management activities independently.
  • Orientation toward accomplishing strategic business goals.
  • Ability to handle multiple priorities.
  • Detail- and results-oriented with a focus on quality.
  • Proficiency with MS Word, Excel, and PowerPoint.

This position would sit in our Boston, MA or Wayne, PA office

Job ID: R1012312