Associate Director / Manager, QA Systems Compliance Office (SCO) - (R1011923) in Durham, NC at IQVIA™

Date Posted: 5/27/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Durham, NC
  • Experience:
    Not Specified
  • Date Posted:
    5/27/2018
  • 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 - Systems Compliance Office (SCO) one will work consultatively with IT/Technology project delivery and system support teams to ensure that IQVIA computerized systems continuously meet internal quality objectives and regulatory compliance requirements.  The Associate Director / Manager, SCO will support the project and validation planning for new systems delivery efforts, perform QA review of deliverables, respond to quality issues, guide root cause analyses and CAPA activities and lead QA internal audits of validated computerized systems.   Assignments may also include providing Subject Matter Expertise (SME) to process improvement efforts for within scope of agile based systems delivery and ITIL-ITSM based operational support activities.  

RESPONSIBILITIES:
  • Support planning of IT system delivery efforts with specific focus on ensuring employment of quality focused approaches to Computerized System Validation (CSV).
  • Work with IT systems delivery or IT product support organizations to ensure their understanding and application of the principles behind Computer System Validation (CSV) activities
  • Perform QA review and approval of IT systems delivery project deliverables key to successful validation
  • Drive or assist with the analysis of Root Cause and CAPA Plans for quality issues (QI’s) related to technology and IT good practices; ensure accurate record keeping for QI’s in our Trackwise based system
  • Perform audits of IT / Technology platforms and support practices at key points across the product lifecycle and make recommendations for process improvements than leverage IT best practices
  • Host, or support the hosting of customer audits specific to CSV & prepare corrective action plans.
  • Interface with IT project managers, IT product support managers and IT subject matter experts (SME’s) to discuss quality & compliance practices and issues.
  • 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

Bachelor’s degree with a minimum of 5 - 7 years experience in a QA or QC role specific to IT Validation, preferably in GCP environment.
  • Expert knowledge, hands on experience with key regulations, principles and practices in Computerized Systems Validation
  • Strong knowledge in IT Project Delivery best practices as might be represented in CMMi or similar SDLC frameworks.
  • Strong knowledge in IT product support practices as might be represented by ITIL ITSM
  • Good knowledge in GCP compliance and CRO business operations
  • Ability to establish & maintain effective working relationships with coworkers, managers & clients.
  • Strong oral and written communication skills
  • Skills with Trackwise, MS-Office Suite of tools required,
  • Experience with IT Project Tools such as HP Quality Center, TopTeam, Jira or similar tools desired.



EEO 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™.


Job ID: R1011923