The Senior QMS Validation Systems Analyst is a critical member of the IT QMS-Corporate Systems team with a broad set of responsibilities. Working in a dynamic, collaborative team environment, the successful candidate will be responsible for supporting Insulet's Quality Management Systems (QMS), Programs and Computer System Validation activities through business processes requirements, analysis of business problems, analytics, proposal/design/implementation of technical solutions, and continued development of the partnership with our Quality and Regulatory (QARA) Organizations. The Senior QMS Validation Systems Analyst will focus on projects and processes related to QMS applications including validation, process improvement and guidance, system documentation, system administration, production support, IT quality control and testing as needed. The ideal candidate will have a demonstrated ability to comprehend business process and context, while also having the knowledge and expertise to guide validation and other project activities appropriately.
* Initiate and lead information gathering discovery meetings with stakeholders at all levels, both internal and external to the organization. * Provide support and troubleshooting as it pertains to existing Quality Systems * Work with the Vendor or other partners to build deployment plans and support production deployments * Lead the Change Management process as it relates to any system changes to the Quality applications * Triage support issues, work with the vendors or other teams on resolving the issues * Coordinate, lead and document test activities. * Lead and/or support computer system validation efforts for QMS applications ensuring adherence to internal procedures, industry practices such as ISPE GAMP 5, and applicable regulations such as FDA 21 CFR Part 11, EudraLex Annex 11, SOX and cGMPs. * Creates and/or oversees the creation of validation deliverables including but not limited to Validation Assessments, Validation Plans, Test Plans, Test Protocols, Test Reports, test scripts, Validation Summary Reports and Trace Matrices, as needed to support local and enterprise system implementation in a regulated (FDA) environment * Leads and facilitates the review and approval of validation deliverables * Ensures that all validation deliverables are prepared in accordance with Insulet guidelines, policies and procedures * Perform complex systems analysis work; conduct requirements gathering/analysis via information gathering sessions with business users and technical staff. * Conduct and document analysis of existing business processes; recommend process improvements. * Understand, document, review and approve Business and Functional Requirements, use cases, scenarios, process flows, system interface diagrams, test protocols and test reports. * Work with business stakeholders in the QARA organization, IT, and vendors to deliver and maintain validated solutions that comply with Insulet SOPs, Procedures, and the Code of Federal Regulations (CFR) as it relates to medical devices. * Represent business interests in working with vendors to design a solution that accurately represents the business requirements. * Support all aspects of building new capabilities, enhancing, and supporting QMS and related systems in collaboration with IT leadership and Project Management. * Assist with the development of training materials and support 'train the trainer' sessions with business SME's to improve adoption and efficient use of all systems related to the QMS. * Create, configure and manage complex workflows in the QMS as they pertain to business process. * Create functional design documentation based on business requirements. * Communicate effectively with business users on the status of enhancements, projects and open production support tickets. * Perform other duties as assigned.
Education and Experience
* Bachelor's Degree and/or equivalent combination of education and experience. * At least 5 years of experience working with Quality Management System(s). * At least 5 years of experience working on projects or programs related to Quality/Regulatory groups. * Proven knowledge of the software and systems development life cycle. * Strong experience and knowledge of requirements gathering tools and techniques. * Medical Device experience is a plus. * Working knowledge of CAPA, NCMR, Deviations, Complaint Handling, MDR/eMDR, GxP, 21 CFR Part 820 is required. * Strong experience and knowledge of the PLM, QMS, EAM, SPC is a plus * Experience with Trackwise Digital Complaints is a plus * Experience with Salesforce.com is a plus * Experience supporting or working with an IT QMS organization, preferably in the pharmaceutical, medical device, or other regulatory controlled industry. * * Skills/Competencies: * Self-sufficient, flexible, and motivated team player capable of managing several activities simultaneously. * Ability to work in a deadline focused, dynamic environment, consistently produce deliverables within agreed upon timelines. * Ability to analyze problems and develop solutions. * Excellent communication, influencing and negotiating skills are critical. * Ability to analyze business processes, design process improvements, and train business users to the new processes. * Excellent writing skills. Must have the ability to express strategy, technical knowledge, and processes in easily understood presentations. * Positive, results driven, rational, logical, team player. * Ability to rapidly learn and take advantage of new concepts, business models, and technologies. * Ability to work independently & on multiple projects against deadlines. * Experience in the healthcare, pharma or medical device industry a plus.
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