Lead Quality Control Auditor (Office - Based) - IQVIA Biotech (R1099626) in Morrisville, NC at IQVIA™

Date Posted: 10/9/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    Not Specified
  • Date Posted:
    10/9/2019
  • Job ID:
    R1099626

Job Description

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.

BASIC FUNCTION:

Develop and maintain a quality control program that reviews all client deliverables produced by the Information Technology and Clinical Processing and Analysis departments

AUTHORITY:

  • The Lead Quality Control Auditor has the authority to evaluate, and accept or reject, items submitted for Quality Control evaluation.
  • When Quality Control materials are rejected, the Lead, QC Auditor will review this action with their manager.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

  • Primarily responsible for quality control processes relating to customer deliverables.
  • Assist with management of QC resourcing and Sponsor deliverable timelines
  • Provide QC support for the Biostatistics, Clinical Programming, Data Management, Information Technology, SAS programming groups.
  • Provide final QC review of all study documents and other client documents (e.g., database QC, Inform QC, data management specifications, SAS output) before they are delivered.
  • Assist with the evaluation of quality control processes.
  • Assure process compliance with all regulatory and IQVIA Biotech SOPs.
  • Secondarily responsible for oversight of a selected group of projects and QC Auditors: 
  • Coordinate project deliverables with QC leads and QC manager.
  • Manage the timelines and budgets for each project.
  • Oversee designated QC auditors, specifically,
  • Coordination of team meeting attendance, communication of deliverables and CCB coverage for selected group of projects.
  • Mentor on quality processes and advise on documentation.
  • Assure notebooks for each project are audit ready.

KNOWLEDGE, SKILLS AND ABILITIES:

  • Knowledge of clinical research process and methodology.
  • Understanding of current GCP, ICH, and FDA guidelines and regulations applicable to conduct of clinical research.
  • Knowledge of quality control processes and procedures.
  • Ability to pay careful attention to details and deliver quality work within expected timelines.
  • Ability to plan long-range needs while assuming responsibility for daily details with a high degree of accuracy.
  • Excellent organizational and program documentation skills, highly detail-oriented.

MINIMUM RECRUITMENT STANDARDS:

  • Bachelor’s Degree and 4 years experience performing quality control functions or equivalent combination of education and experience required. 
  • Excellent interpersonal and organizational skills required.

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: R1099626