IT Senior Project Manager

Insulet Corporation ,
London, Greater London
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Overview

Job Description

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating. We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it! Position Overview: The Senior Project Manager , is responsible for providing leadership, management and direction to personnel engaged in planning, implementing, testing, and monitoring of computer systems and software that support Insulet's fast growing corporate and commercial footprint, including Manufacturing, Supply Chain, QA/RA and Customer focused business processes and activities. He/she is recognized as an expert in Program and Project Management as well as infrastructure qualification and computer software validation. The Senior Project Manager assures that Insulet's processes reflect current industry best practice and satisfy regulatory requirements. Provides IT project planning, coordination and reporting. Works collaboratively with business, IT staff and manages vendor activities. Leads efforts defining and implementing new software systems, enhancements to existing system and process improvements as needed. Provides end user support as required. Working in a dynamic, collaborative team environment, the successful candidate will lead project teams that will support Insulet's expansion with new products, new markets and new functions through business analysis and IT leadership across the entity. The ideal candidate will have a demonstrated ability to lead cross-functional and remote project teams, a track record of delivering results and the ability to focus on enabling business initiatives through IT. Responsibilities: * Plan and manage large, complex projects including requirements gathering, defining deliverables, work breakdown structures, effort estimates and project schedules. Focus is on defining and delivering new processes and functionality as well as process improvements, system improvements and ensuring regulatory compliance as needed. * Lead programs, system implementations and upgrades to deliver expanded functionality for Insulet's Commercial and Corporate business functions. * Manage project teams consisting of internal business analysts, systems analysts and subject matter experts as well as extended teams of consultants and external partners. * Lead business requirements and design efforts for all related projects. Oversee development and or integration efforts. * Partner with Insulet Leaders in the Corporate and Commercial functions to deliver successful project and program initiatives. * Create project, risk mitigation, and communication plans, identify resource requirements, identify project costs, manage project budgets and create other project deliverables. * Lead testing efforts and define deployment and cutover plans. Ensure projects meet acceptance criteria for successful go live(s). * Manage the coordination of project activities with business owners/stakeholders and project team. Communicate with all project stakeholders effectively as needed. * Review validation documentation including: specifications, validation plans, protocols (IQ/PQ/OQ), test plans, summary reports, risk assessments, SOPs and Trace Matrices as required. * Act as primary liaison with system vendors on projects or resolving technical issues. Education and Experience: * Five years of experience in a GMP/FDA regulated environment (preferred) or other regulated industry. * Five years of experience managing software validation projects to meet industry regulatory requirements (preferred). * Five years of project management experience with Operations, Supply Chain or RA/QA systems such as ERP or Quality Management Systems. * Experience working with cross-functional teams, remote teams and Contract Manufacturers. * Strong understanding of Medical Device or Pharmaceutical Industry practices. * Understanding of patient data privacy requirements and impacts to systems and processes. * PMP or at least ten years of IT Project Management Experience. * Experience with SDLC or Agile project implementation methodologies. * BS in an IT-related discipline such as Computer Science or equivalent experience. Skills/Competencies: * Action oriented self-starter who can drive complex projects with minimal guidance/oversight. * Strong functional business knowledge including Quality, CRM, Supply Chain and Operations. * Capability to lead systems implementations including meeting schedules, monitoring and resolving issues, achieving budget and managing change control processes. * Ability to be empathetic, yet firm, with challenging customers, and to

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