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