Quality Lead (R1015313) in Boston, MA at IQVIA™

Date Posted: 5/13/2018

Job Snapshot

  • Employee Type:
  • Location:
    Boston, MA
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

Job Description

Job Summary
This position is responsible for Data Solutions and Site Start Quality Management System (QMS) monitoring and maintenance.
Summary of Essential Job Functions

    Coordinate and support continuous improvement of DrugDev QMS.
    Assist in developing training matrix related to QMS and delivering such training as necessary.
    Lead and support gap analysis of Data Solutions and Site Start organizations processes, SOPs and Work Instructions. 
    Support implementation and maintenance of Data Solutions and Site Start organizations SOPs and Work Instructions as applicable.
    Maintain electronic repository of Quality Documentation and project specific Central Files as applicable. 
    Coordinate and support assignment and tracking of required QMS training for  Data Solutions and Site Start organizations as applicable
    Coordinate and support performing QMS Internal Audits per applicable DrugDev policies and procedures.
    Support sponsor audits of Data Solutions and Site Start business units and other business units as needed.
    Provide advice and consulting in quality area for internal DrugDev personnel.
    Other duties as needed

    ICH guidelines and FDA, IRB/IEC regulations 
    Experience with sponsor and internal audits and study regulatory documents
    Experience with User Acceptance Testing
    Decision making/judgment
    Problem solving/analysis
    Project Management
    Sense of urgency 

Supervisory Responsibilities

This position does not have responsibility for managing people.  

Minimum Experience Requirements

     B.A./B.S. preferably in a business or science/health care field, nursing degree, or equivalent degree and/or related experience
    Prior experience in working with electronic document management system(s) or similar portal environment desired
    Basic understanding of the clinical trial process and ICH guidelines and FDA, IRB/IEC regulations preferred
    Experience working in a regulated environment or clinical trials
Skill Requirements

    Strong PC skills (i.e. Microsoft Office)
    Proven organizational skills
    Superior interpersonal communication and presentation skills
    Comfortable working in a global company environment

Job ID: R1015313