Insight Global is looking for an IT PM to support a local client. This PM will play a pivotal role in implementing an FDA-regulated Quality Document Management System (QDMS) by ensuring the project adheres to Agile principles while meeting strict regulatory requirements. The client will implement Singlepoint. The PM facilitates the Agile framework by organizing sprints, conducting daily standups, and managing retrospectives to ensure continuous progress. The PM collaborates with the Product Owner and team to prioritize tasks such as system validation, compliance with 21 CFR Part 11, and user training. By fostering a structured yet flexible approach, the PM ensures the team delivers high-quality results within the constraints of FDA regulations. In addition to driving Agile processes, the PM supports compliance by promoting regulatory awareness, coordinating with subject matter experts, and tracking tasks related to validation and risk management. They act as a bridge between cross-functional teams, such as IT, Quality Assurance, and Regulatory Affairs, to ensure alignment on project goals and regulatory standards. The PM also facilitates workshops, manages stakeholder expectations, and ensures that all SDLC validation and testing activities are properly documented for FDA audits. This collaborative approach helps mitigate risks and ensures the system is both functional and compliant. Finally, the PM plays a key role in training and change management to ensure successful adoption of the QDMS. They coordinate user training sessions, address resistance to change, and promote system adoption across the organization. By monitoring progress, gathering feedback, and implementing continuous improvement strategies, the PM ensures the system meets both business needs and regulatory requirements. They should be able to balance Agile principles with FDA compliance.
Pay rate is between 60 - 70/hr based on experience.
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Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.