Covance

  • IT Software Quality Lead

    Job Location(s) US-NC-Raleigh-Durham
    Job Number
    2018-24093
    Job Category
    Information Technology
    Position Type
    Full-Time
  • Job Overview

    Reporting to the Sr. Manager, IT Software Quality, the Lead, IT Software Quality is accountable for IT validation activities. The Lead, IT Software Quality will provide guidance for IT QC/validation initiatives for the business units that they support. The Lead, IT Software Quality will liaise with IT Project Managers to execute the project-specific IT validation strategy by coordinating and guiding computer systems validation activities.

     

    The Lead, IT Software Quality will work regularly with Program/Project Managers and respective leaders or representatives from Global IT Quality, Global IT Support and IT Business Analysts. The Lead, IT Software Quality will provide oversight for project-specific IT Computer System Validation projects and manage IT validation aspects within a highly regulated environment.

     

    Validation Strategy

    • Assist with establishing, reviewing, executing, and ensuring compliance with governmental regulatory requirements, policies, standards, and procedures related to processes for Computer System Validation and qualification of infrastructure components.
    • Advise the project team on and be responsible for Computer System Validation strategy and documentation of product functionality across system releases.
    • Coordinate project-specific Computer System Validation efforts, including coordination of the execution of the test plan.
    • Recommend proper controls for the Covance's computer systems to ensure the reliability of applications and infrastructure, as well as the integrity of data and safety of subjects.
    • Utilize tools for conducting and executing Computer System Validation.

     

    Testing

    • Provide direction to assure that IT applications and infrastructure components possess the necessary level of testing, and required documentation to comply with applicable GxP regulations and client requirements/expectations. 
    • Ensure compliance with Covance standard testing methodologies, procedures, and practices.
    • Prepare validation and test strategies for IT initiatives, and present to project teams.
    • Work with Project teams to identify test requirements and advise on the design of testing phases, as well as documentation of test plans & test case specifications to meet system needs.
    • Advise on/be involved in the performance of application, functional, usability, performance load-stress, & user acceptance tests.
    • Ensure that the testing is completed on time and that it addresses all user and functional requirements as defined during the requirement definition process.
    • Perform documentation reviews and conduct analyses of validation process issues and testing results.
    • Ensure that software faults are identified and documented, and coordinate with development staff so that testing issues are isolated and resolved.
    • Ensure that all necessary project-specific Computer System Validation documentation is produced, and for reviewing the material for correctness, completeness, and clarity.

     

    Partnerships

    • Periodically conduct training for IT staff and business associates as to their respective responsibilities within the IT validation methodology.

    Education/Qualifications

    Bachelor’s (or experience level which may be substituted for level of education).

    Professional designations/certifications/licenses required

     

    • 4+ years’ experience in a FDA (GXP) regulated industry (i.e. such as pharmaceutical, medical device, or biotechnology)
    • Bachelor’s Degree required (ex. science based, operations research, technology, etc.)
    • Industry related certifications preferred (e.g. PMP, CQE, CQM, etc.)

    Experience

    • 5+ years’ experience in execution of projects, 3+ years partnering/guiding clients at project levels
    • Familiar with various validation methodologies (SDLC), and their implementation in an IT organization
    • Knowledgeable of regulatory compliance requirements in the pharmaceutical and drug development industry (GXPs)
    • Implementing and maintaining risk-based validation model & strategies
    • Creative approach to resolving technical issues, and balancing business needs with validation requirements
    • Program & Project Management experience – ability to plan, organize, and execute work across multiple initiatives to drive delivery of validation commitments
    • Proven ability to coordinate strong teams, and ability to manage multiple priorities
    • Demonstrates self-motivation to lead teams on a unified validation strategy, while achieving department goals, objectives, and initiatives
    • Exceptional verbal, written, presentation, interpersonal skills, and ability to command respect of others

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