Iqvia Holdings, Inc.
Job Overview Responsible for the management and oversight of IT operational activities specifically for R&DS; ITs software quality assurance (SQA) and Computer Systems Validation (CSV) function globally. This role works under the leadership of the Head of SQA and CSV, RDS IT. This individual will work in close collaboration with project team members and other IDEA consultants in functions noted below as it relates to functions regarding SQA & CSV Standards, Tools, and SDLC methodology: • Guide teams on RDS IT SQA tools, standards, and methodologies for software development, testing and implementation. • Help guide/update IT SDLC SOPs, Work Instructions, templates, tools and other processes for continuous improvement.
This involves periodic review of the standardized document library. • Guide teams through through regulatory adherence, 21 CFR Part 11 in software development. This involves help on software classification and release risk rating. • Help oversee adherence and recertification processes for CMMI Maturity Levels • Guide teams as needed through change management related to best practice software engineering: Agile, Dev/Ops. • Help with change management, training and training compliance as it relates to SDLC processes. • Participate in larger projects or initiatives as required as a SQA or CSV consultant • Assist in managing team resources and delegating tasks commensurate with skill level, evaluating workload and quality through regular review • Help teams to address that any quality incidents and CAPAs identified in QA or customer audits are properly addressed Qualifications • Bachelors Degree Computer Science, Information Technology or related discipline Req • Equivalent combination of education, training and experience in lieu of degree may be considered Req • Strong people skills, establishing and maintaining effective working relationships with peers, managers and clients • Relevant technical, functional and/or process expertise • Excellent computer literacy, organizational, communication and problem-solving skills • Detail-oriented, analytical and self-motivated with strong written and verbal communication skills • Prior work experience in SDLC processes, specifically validation and quality management • Ability to work in a fast-paced environment and adjust focus and workflow based on changing deadlines and needs • Effective team player with ability to complete tasks and projects while monitoring various aspects of operations • Excellent interpersonal skills, working in collaboration with onshore and offshore teams as well as third party vendors • Decision making and problem-solving ability, taking timely action and demonstrating judgment to know when to escalate and ask for guidance
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