Associate Director, QA CAPA Governance - (R1011923) in Durham, NC at IQVIA™

Date Posted: 9/27/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Durham, NC
  • Experience:
    At least 3 year(s)
  • Date Posted:
    9/27/2018
  • Job ID:
    R1011923

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.

Description

As a member of the QA CAPA Center of Excellence, this role will work consultatively with QA colleagues, functional staff and project delivery teams to ensure that IQVIA issue management, CAPA practices and CAPA governance continuously meet internal quality objectives and regulatory compliance requirements.  The Associate Director / Manager, CAPA Governance will support the project planning for new CAPA systems delivery efforts, ensure effective CAPA governance, assure timely functional and project-level identification and submission of quality issues ,and  guide root cause analyses improvements and CAPA champion activities. 

RESPONSIBILITIES:
  • Support development of a streamlined issue management framework, with a focus on ensuring effective CAPA governance 
  • Work with functional and project management organizations to ensure their understanding and application of CAPA governance and development of CAPA Champions 
  • Drive improvements in the timeliness and quality of investigations, Root Cause analysis and CAPA Plans for quality issues (QI’s) 
  • Perform assessments of CAPA practices at key points across the product lifecycle and make recommendations for process improvements that leverage industry best practices
  • Support customer audits specific to CAPA, including responses to any findings 
  • Interface with functional and project leaders to drive effective CAPA governance to discuss quality & compliance issue escalations.
  • Participate in risk assessment and planning activities within the project delivery or product support live cycle.
  • Participate in or lead teams for special process improvement or risk mitigation projects as assigned. Teams may be cross functional.
  • Perform other duties as needed.


Job Requirements

Job Requirements:

  • Bachelor’s degree with a minimum of 3 years’ experience in a QA role specific to issue management and CAPA, preferably in a GCP or PV environment.
  • Strong knowledge in issue management and CAPA governance best practices as might be represented in TransCelerate or similar clinical QMS frameworks.
  • Expert knowledge, hands on experience with key regulations, principles and practices in GCP and/or PV 
  • Good knowledge of CRO business operations
  • Ability to establish & maintain effective working relationships with coworkers, managers & clients.
  • Strong oral and written communication skills
  • Skills with Trackwise (or similar CAPA systems) and MS-Office Suite of tools required
  • Experience with risk management standards (e.g. ISO 31000 or similar)  desired.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled
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™.

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™.


Job ID: R1011923