Staff IT QMS Solution Architect

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

Job Title: Staff IT QMS Solution Architect

Department: IT

Manager/Supervisor:    Senior Manager Quality and Regulatory System, Information Technology

FLSA Status: Exempt

SOP Group: IT

Company Overview:

Insulet started in 2000 driven to achieve our mission of enabling our customers to enjoy simplicity, freedom and healthier lives using our Omnipod product platform. In the last two decades we have improved the lives of hundreds of thousands of patients who have insulin-requiring diabetes by using innovative technology that is wearable, waterproof, and lifestyle accommodating. We are on an exciting trajectory of significant growth and global expansion enabling us to reach more patients around the globe. We are looking for highly motivated, performance driven individuals who want to be part of building our Center of Excellence and be at the forefront of our rapidly growing global footprint. We are looking to hire amazing people who are guided by shared values and desire to exceed customer expectations. Our continued success depends on it.

Position Overview:
The Staff IT QMS Solution Architect is a critical member of the IT QMS-Corporate Systems team, responsible for supporting Insulet's Quality Management Systems (QMS), programs, and validation activities. This role requires advanced technical expertise and leadership in configuring, scripting, and customizing platforms such as Veeva Promomats, Veeva Medcomms, Arena PLM, and IT Polarion, and future QMS platforms as they are introduced ensuring robust system architecture, seamless integration, and compliance with regulatory requirements.

Responsibilities:

• Lead hands-on configuration, scripting, and customization of QMS platforms including Veeva Promomats, Veeva Medcomms, Arena PLM, and IT Polarion to meet evolving business and regulatory needs.

• Architect, design, and implement system integrations between QMS platforms and other enterprise systems, ensuring data integrity and process automation.

• Develop, maintain, and validate custom scripts, workflows, and automation tools to optimize system performance and user experience.

• Serve as the technical subject matter expert for platform upgrades, migrations, and advanced troubleshooting, providing guidance to junior analysts and cross-functional teams.

• Serve as the technical lead for AI initiatives within QMS systems, driving the integration of intelligent automation, predictive analytics, and machine learning capabilities to enhance quality processes, data integrity, and regulatory compliance.

• Collaborate with business stakeholders, IT, and vendors to deliver validated solutions that comply with Insulet SOPs, CAPA's, procedures, and applicable regulations (e.g., 21 CFR Part 820, GxP).

• Oversee system validation activities, including authoring and executing test protocols, managing validation documentation, and ensuring audit readiness.

• Create and manage complex workflows and functional design documentation based on business requirements, with a focus on technical scalability and maintainability.

• Initiate and lead technical discovery meetings with stakeholders at all levels, both internal and external to the organization.

• Mentor and provide technical leadership to team members in best practices for system configuration, integration, and validation in regulated environments.

• Perform complex business and systems analysis work; conduct requirements gathering/analysis via information gathering sessions with business users and technical staff. Develop supporting process flows.

• Conduct analysis of existing business processes; recommend process improvements.

• Understand 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 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.

• Coordinate test activities.

• Initiate and lead information gathering discovery meetings with stakeholders at all levels, both internal and external to the organization.

• Perform other duties as assigned.
  
   

Minimum Requirements:

Education and Experience:

• Bachelor's Degree and/or equivalent combination of education and experience.

• At least 8 years of experience working with Quality Management Systems.

• At least 4 years of experience in a Business Analyst , Systems Analyst , Architect, or Development role.

• At least 2 years of experience on projects or programs related to Quality/Regulatory groups.

• Training in QMS system administration and/or development preferred.

• Working knowledge of CAPA, NCMR, Deviations, Complaint Handling, MDR/eMDR, GxP, 21 CFR Part 820 required.

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.

• Working knowledge of CAPA, NCMR, Deviations, Complaint Handling, MDR/eMDR, GxP, 21 CFR Part 820 a plus.