QA Manager (R1078949) in Durham, NC at IQVIA™

Date Posted: 8/12/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Durham, NC
  • Experience:
    Not Specified
  • Date Posted:
    8/12/2019
  • Job ID:
    R1078949

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. Collaborates with Quality counterparts at customers and with internal project teams to proactively promote, support and facilitate proactive quality through the identification and management of risks and implementation of quality improvement activities.  Provide consultation in interpretation of regulations, guidelines, policies, and procedures.

Summary of Responsibilities:

  • Collaborates with Quality counterparts at customers and with internal project teams to proactively promote, support and facilitate proactive quality through the identification and management of risks and implementation of quality improvement activities.
  • Provides actionable insights from quality and operational data analysis and proactively working with the customer and the account team to develop action plans to drive continuous improvement.
  • Analyzes trends in quality issue reporting and timeliness to ensure adherence to quality issue management requirements across project teams
  • Supports the management and resolution of significant issues relating to quality;
  • In collaboration with Quality Management, ensures projects are inspection ready starting at the design stage.
  • Drives inspection readiness activities for the customer, including contributing to mock inspections by/of the customer
  • Contributes to the development of the global risk-based internal audit plan.
  • Advises customer Quality counterparts on the strategy for regulatory inspections and collaborates in the preparation for and management of inspections at customer offices and, as necessary, at investigator sites.
  • Interfaces with senior management to discuss quality and compliance issues
  • Interfaces with business development and operations to identify business opportunities
  • Hosts and/or supports customer audits and ensures appropriate and sustainable action plans are developed and implemented.
  • 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 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.

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: R1078949