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16672-QA Dir (R1071311) in Research Triangle Park, NC at IQVIA™

Date Posted: 6/12/2019

Job Snapshot

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.

Role description for IT Compliance Functional Strategy Lead

Role Purpose: To be a trusted partner to IT Heads and teams, providing prospective, strategic QA input into operational improvement initiatives and QA analytics and insights to drive continuous improvement, ensuring robust and effective issue management, and assisting operations to maintain inspection readiness at all times in rapidly evolving clinical development and regulatory environments.

Role Responsibilities:

  • Process Assessments
    • Conduct annual Process Robustness Assessment and ongoing risk analysis of the IT functions’ systems and processes to recommend process audits for the Global Annual Audit Plan
    • Review process audit plans and audit reports, and support the audit team in agreeing the CAPAs
    • Work with IT counterparts to maintain Key Core Processes (KCPs) and associated EDA classifications
    • Monitor progress with Process Owners’ strategies and action plans to improve existing KCPs
    • Support the investigation of current/recurring key issues or findings by reviewing the existing processes, CAPAs to identify gaps and make recommendations to the Lead QA, IT and operations.
  • CAPA Management
    • Support and oversee/facilitate, where required, the processing of Quality Issues in accordance with CS_OP_002, (Manage Critical Process-Related QIs and Critical Multi-Customer Related QIs as Lead QA. Provide consultation on the review of CAPAs, Critical Notification Forms and Serious Breaches).
    • Maintain oversight of the status of approved preventive actions to address process improvement opportunities.
    • Work with IT and Operational Heads and their representatives to ensure efficient and timely processing of audit reports/findings and Quality Issues in their domain.
  • Process Improvement Initiatives and New Service offerings
    • Monitor, catalogue, proactively contribute to, track the actions agreed from, and work with IT and Operations to establish the effectiveness of improvement initiatives undertaken by the function
    • Monitor, catalogue, proactively contribute to the development of new IT service offerings, and work with IT and Operations to establish the effectiveness of those offerings  
    • Provide consultancy and input into incremental process improvements, such as advising on SOP content
  • Customers and Regulators
    • Maintain an up-to-date knowledge of emerging regulations, and emerging/changing interpretations of regulations, and changing expectations of regulatory inspectors, assess the risks and feedback recommendation to IT and Operations, and be available to support operational management in interpreting regulations.
    • Maintain strong links with Customer Account Leads to monitor emerging/changing expectations of customers with respect to IT systems and processes, assess the risks and feedback recommendation to the function
    • Host or support Regulatory inspections as the SME for IT services
    • Host or support customer audits as the SME for IT services
  • Insights and Reporting
    • Review audit findings and Quality Issue/ Nonconformance events as they relate to IT and Operations on an ongoing basis
    • Conduct trend analyses
    • Identify QA insights to feedback to IT and Operational management
    • Produce periodic QA reports on IT operational performance
    • Facilitate periodic management quality reviews with IT functions, and capture and track agreed actions
    • Collaboration with Quality Managers (QMs) to remain aligned on emerging Operational risk trends
  • Support QA colleagues
    • Support QA colleagues in the oversight of the practices of other Business Areas conducting work allied to IT.
    • Provide updates and overviews of the insights and initiatives associated with IT
    • Share the identified KCP level action plans with others in QA to prevent repetitive preventative action plans
  • Contribution to Functional QA Strategy
    • Contribute ideas for improvements in the services of the Functional Strategy Team, and to the development of new, more impactful, efficient and effective ways of working.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Circa 7 years’ experience working in IT Quality Assurance.
  • Experience working with a CRO is desirable, but not a pre-requisite
  • Experience in hosting customer audits and regulatory inspections is an advantage, but not a pre-requisite
  • String leadership qualities and expereunce in line management
  • Strong knowledge of pharmaceutical research and development processes and regulatory environments.
  • Detailed working knowledge of quality assurance processes and procedures.
  • Strong interpersonal skills and the ability to positively influence and guide others whilst building and maintaining effective working relationships.
  • Excellent problem solving, risk analysis and negotiation skills.
  • Possess experience in conducting audits, writing audit reports and analysing audits.
  • Demonstrated ability to lead and manage multiple responsibilities.
  • Ability to identify functional constraints and identify solutions.
  • Ability to coordinate timelines with internal customers and external vendors.
  • Demonstrated experience of maintaining up to date knowledge of regulatory requirements, including changes in requirements and expectations.

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: R1071311