Senior QMS Validation Systems Analyst (Remote/Flexible)

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.

Position Overview:
The Senior Business Systems Analyst is a critical member of the IT Quality Regulatory, Medical Affairs 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 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 BSA is a primary QMS Subject Matter Expert and will focus on projects and processes related to QMS applications including system documentation, system administration, production support, IT quality control and validation. The ideal candidate will have a demonstrated ability to comprehend business process and context, while also having technical skills to design and configure appropriate technical solutions.

Responsibilities:

• 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 Insulet Business Teams, 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.
• Performs other duties as assigned.

Minimum Requirements:
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 4 years of experience working in a Business Analyst role.
• At least 2 years of experience working on projects or programs related to Quality/Regulatory groups.
• Training in QMS system administration and/or development preferred.
• 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, , GxP, 21 CFR Part 820 is required.
• Strong experience and knowledge of the Seimens Polarion ALM (Application Lifecycle Management) Tool
• Experience with Service Now or traditional support ticket and change management system is a plus
• Proven ability to provide business analysis and system configuration deliverables related to process improvement.
• Experience with Agile and traditional methods of project management, requirements gathering and analysis is desired.
• 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.

NOTE: This position is eligible for 100% remote working arrangements (may work from home/virtually 100%; may also work hybrid on-site/virtual as desired). #LI-Remote