QA Director (R1096200) in Durham, NC at IQVIA™

Date Posted: 10/16/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Durham, NC
  • Experience:
    Not Specified
  • Date Posted:
    10/16/2019
  • Job ID:
    R1096200

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:

 This position is a QA Director in the Customer Strategy team who will serve as the strategic quality engagement lead for one or more key (i.e. accounts with established governance structures, account directors and multiple projects) IQVIA customers.  The SEL role includes the following activities for the assigned customers. The QA Director is responsible for serving as a strategic partner to external customers and internal project teams to drive GCP and PV quality, ensuring that that projects and deliverables are compliance with regulatory requirements and industry best practices   This is a highly visible and important position within QA and requires both strategic vision and personal tactical execution.

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.
  • Prepares for and actively participates in relevant Governance/partnership level meetings e.g. Quality Councils/ Joint Operations Committee (JOC) or equivalent meetings with customer Quality counterparts.
  • 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.

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 applying proactive quality approaches for clinical trials.
  • Strong negotiation and influencing skills; demonstrated ability to work constructively and effectively at all levels across functions as well as with external customers 
  • Superb and polished ability to consistently present information in a clear, compelling, and understandable format, tailoring presentations to the context and audience.  
  • Demonstrable experience and ability to utilize analytics to make data-driven decisions and assess impact of interventions 

Required Education and Experience:

  • Bachelors degree in a scientific or healthcare-related field
  • Demonstrated experience leading and successfully delivering on high-profile quality initiatives with senior executive leadership visibility.
  • 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: R1096200