Manager, Quality (R1038164) in Boston, MA at IQVIA™

Date Posted: 8/9/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Boston, MA
  • Experience:
    Not Specified
  • Date Posted:
    8/9/2018
  • Job ID:
    R1038164

Job Description

Manager, Quality


Job Summary


This position is responsible for maintaining Quality Management System (QMS) and providing quality oversight.  The Manager of Quality is responsible for maintaining a corporate Quality Management System that promotes customer satisfaction and positively impacts performance of the company.  The Manager of Quality initiates and implements quality improvement activities as appropriate to raise performance of the company services; additionally it guides, mentors designated quality representatives as well as trains company employees regarding their impact on the QMS. 


Summary of Essential Job Functions


Responsibilities include:
 Implementing and maintaining company Quality Management System
 Managing and coordinating sponsors quality, privacy, security and part 11 assessments
 Managing and coordinating internal audits and supporting client audits
 Coordinating and maintaining company Quality Management System (QMS) 
 Managing and maintaining company-wide quality and validation documents templates
 Managing and supporting QMS training
 Building strong relationships with internal and external clients, providing strategic support and driving client satisfaction with the quality management and quality oversight
 Providing quality oversight for critical business projects
 Maintaining company-wide Corrective and Preventive Actions (CAPA) program 
 Consulting project teams on quality management and validation deliverables
 Facilitating quality related  internal project team meetings and calls 
 Supporting project teams during quality related sponsor meetings and calls
 Other duties as assigned

Competencies
 Strong interpersonal and communication skills (both written and verbal).
 Understanding clinical trials.
 Knowledge and experience with 21CFR Part 11 and GXP.
 Knowledge and experience of Agile SDLC and system validation.
 Ability to work in a team environment and excellent global team-based problem solving skills.
 Focus on quality, results and orientation toward accomplishing strategic organizational goals.
 Excellent project management skills. 
 Ability to handle multiple, rapidly changing and sometimes conflicting priorities.
 Prior experience working with quality management systems in regulated environment of pharma and medical device companies.
 High energy, self-starter with the ability to work in a global team environment.
 Proficiency with MS Word, Excel, and PowerPoint.

Supervisory Responsibilities

N/A.


Minimum Experience Requirements

 Bachelor Degree in science or business 
 Graduate Degree preferred
 Minimum 8 years of quality, computer systems/software validation, management and project management experience
 Minimum 6 years of quality management and/or validation leadership position 


Skill Requirements

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



Job ID: R1038164