Quality and Compliance Manager (R1079892) in Boston, MA at IQVIA™

Date Posted: 7/16/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Boston, MA
  • Experience:
    Not Specified
  • Date Posted:
    7/16/2019
  • Job ID:
    R1079892

Job Description

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.

Job Summary:
This position is responsible for maintaining the Quality Management System (QMS) and providing quality and compliance oversight.  The QA Manager is responsible for maintaining and enhancing the Clinical Technology Quality Management System that promotes customer satisfaction and positively impacts performance of the company.  The QA Manager initiates and implements quality improvement activities as appropriate to raise performance of the company systems and services; additionally he/she guides and mentors designated quality representatives as well as trains company employees regarding their impact on the process streamlining, improvements, and QMS.
Summary of Essential Job Functions

Responsibilities include:

  • Managing, coordinating, and/or supporting sponsors' quality, privacy, security and 21 CFR Part 11 assessments
  • Managing, coordinating, and/or supporting internal audits and client audits
  • Coordinating and maintaining company Quality Management System (QMS)
  • Managing and/or 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 and compliance oversight for critical business projects
  • Maintaining and/or supporting 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).
  • Prior experience working with quality management systems in regulated environment of pharma and medical device companies.
  • Prior experience with and knowledge of clinical trials preferred.
  • Ability to evaluate and identify gaps in a QMS.
  • Knowledge and experience with Computer System Regulations (e.g. 21CFR Part 11) and GxP.
  • Knowledge of and experience with Agile SDLC and system validation and/or evaluating Computer Systems.
  • Ability to work in a global 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.
  • High energy, self-starter with the ability to work in a global team environment.
  • Proficiency with MS Word, Excel, and PowerPoint.


Minimum Experience Requirements:

  • Bachelors Degree 
  • Graduate Degree and/or professional certifications 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 and project management skills
  • Superior interpersonal communication and presentation skills

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™

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: R1079892