Description
Summary of Qualifications Over eleven years in a regulated environment including custom built applications, clinical based computer systems, IVRS systems, and data acquisition systems. Seven of those years in an IT management role. Successfully lead teams in promoting quality assurance throughout the software development life cycle (SDLC), both Waterfall and Agile/SCRUM methodologies. Successful in the development and implementation of quality principles such as requirements gathering/determination/management, change control, configuration management, project management, and computer system validation. Strategic in identifying gaps in existing procedures, training, documentation, product design, and providing solutions. Excellent interpersonal and relationship management skills with the ability to foster team building, mutual respect, associate development, and accountability. Recognized for being goal oriented, with excellent time management and organizational skills. Summary of Experience Project Management * Experienced in managing technology projects utilizing project management tools and principles. * Oversaw the development of technical solutions to meet business needs, both internal and external resources. * Development of project plans including estimation of resource requirements and timelines, scheduling, budgeting, dependency identification and management, and change management planning. * Managed vendors that were part of application solutions in the best interest of the company. * Project status reporting to key stakeholders, including progress against milestones, issue and risk management details, and budget versus actual costs. * Management of project delivery according to project plans, objectives, budgets, and document progress. * Management of project scope change through defined project change management processes. * Received accolades for seeking opportunities to expand value to the client within current scope and through proposal of project extensions and additional projects. Quality Assurance Management * Oversaw the Quality Assurance department function in regards to computer system validation, process improvement, technical writing, training, and information technology processing across the Americas region. * Development of enterprise-wide Validation Master Plans, Software Requirements Management Plan, and Software Configuration Management Plans. * Educated business partners on SDLC process to ensure the delivery of quality solutions. * Demonstrated strong leadership skills by mentoring, coaching, and giving timely, accurate feedback to team members for development purposes. * Earned the trust of executive leadership, stakeholders, and team members through demonstrated expertise, high quality delivery, and candid insight. * Implemented Quality Assurance Standard Operating Procedures regarding computer systems validation practices. * Educated the implementation teams, support teams, and end-users on both products and policies. * Provided training on FDA regulations for both internal and external business partners. * Conducted and hosted both internal and external third-party vendors in information technology audits in relation to CSV and 21 CFR Part 11. * Coordinated evaluation, development of corrective action plan, and follow-up of quality problems and client grievances related to CSV or information technology processes. Computer System Validation * Management of project issues and risks including: identification, logging, assessment, and action strategies. * Responsible for the development and execution of Installation Qualifications, Operational Qualifications, Performance Qualifications, Validation Test Plans, Functional Requirements Document, System Design Document, User Acceptance Test Plans, Requirements Traceability Matrix, and Validation Summary Reports. * Provided FDA 21 CFR Part 11 consultation and training to both internal and external clients. * Responsible for gathering, documenting, and tracing system requirements throughout the SDLC. * Responsible for developing and executing functional test plans. This included logging of defects, tracking, and re-testing via regression testing. * Collaborated with development team to develop unit or modular test plans.
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