QA Manager (R1106474) in Morrisville, NC at IQVIA™

Date Posted: 11/25/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    Not Specified
  • Date Posted:
    11/25/2019
  • Job ID:
    R1106474

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.

Purpose

A QA Manager is responsible for providing support to management in the promotion and assessment of compliance with regulations, guidelines, and operating procedures.  Manage QA oversight of projects, assignments, and training. Conduct independent audits to assess compliance with regulations, guidelines, and operating procedures.  Prepare and distribute reports of findings to operations staff, management, and customers. Provide consultation in interpretation of regulations, guidelines, policies, and procedures.

Summary of Responsibilities:

  • Plan, schedule, conduct, report and close audit activities in any of the countries involved with Quintiles contracts.  Audits are conducted to assess compliance with applicable regulations/guidelines, customer requirements, Quintiles SOPs and project specific guidelines/instructions.
  • Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers.
  • Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.
  • Provide consultation to customers, functional leads and monitors in interpretation of audit observations and formulation of corrective action plans.
  • Prepare, review and approve corrective action plans
  • Present educational programs and provide guidance to operational staff on compliance procedures.
  • Conduct quality assurance consultancy activities and projects for clients within budget and established timelines.
  • Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
  • Host customer audits
  • Host mock regulatory inspections and regulatory facility inspections
  • Provide training for new Quality Assurance staff.
  • Serve as author of Quality Assurance SOPs as assigned.
  • Advise Quality Assurance management on system audit needs.
  • Act as regional or Global QA Coordinator for assigned customers projects
  • Oversee documentation, reporting, and closure of compliance issues
  • Lead Projects.
  • Train new auditors and staff as required.

Required Knowledge, Skills and abilities:

  • Thorough understanding of GCP, PV, and other relevant quality compliance requirements of major regulatory agencies (FDA, EMA, PMDA) and demonstrated experience interpreting and applying relevant regulations, laws and guidance.
  • Practical experience in conducting internal process, site and vendor audits
  • Practical experience applying proactive quality approaches for clinical trials.
  • Working knowledge of real world evidence and non-interventional studies preferred.

Required Education and Experience:

  • Bachelors degree in a scientific or healthcare-related field
  • Demonstrated experience leading and successfully delivering on GCP audits
  • Minimum 5 years of experience in experience in clinical quality in a pharmaceutical, biotech, or other regulated industry.

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: R1106474