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:

This position is primarily responsible for oversight of Validation & Verification (V&V) activities with a focus on IT GxP Systems. This position is a quality function which supports GxP quality computer software implementation.  This position requires a mid level individual with strong experience in supporting Computer System Validation (CSV) efforts 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.  The Validation lead partners with Business Owners, Technical Owners, Product owners and Quality testing team to create and manage validation deliverables for GxP applications.

Responsibilities:

Coordinate and communicate between V&V team and other departments, in particular Design Quality Assurance (DQA) and subject matter experts (SMEs).Partners with and/or leads Business Teams and cross functional teams to ensure that computerized quality systems (specifically Salesforce Lightning) are compliant with Insulet corporate procedures, FDA Quality System Regulations, 21 CFR Part 11 and GAMP5Creates and/or oversees the creation of validation deliverables including but not limited to Validation Assessments, Validation Plans, Test Plans, IQ Protocols, PQ Protocols, 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.Strong knowledge of GAMP/risk-based approaches to validation (computer software assurance) and good understanding of electronic records.Ensures that all validation deliverables are prepared in accordance with Insulet guidelines, policies, and procedures.Familiar with diverse computerized systems such as ERP, MES, CRM, and validation life cycle management application.Report status to the Test Management and Coordination Team lead for all Insulet V&V team effort under his/her jurisdiction.Supports Business Owners and cross functional teams in the definition and creation of Business Requirements, Functional Specifications and System Specifications as necessary.Work with little to no supervision to fulfill duties in accordance with requirements of the QSR regulations, ISPE GAMP 5®, Insulet corporate policies and procedures.Follows all Insulet policies, guidelines, and SOPs as required.Reviews and complies with the Insulet Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws, and regulations.Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.Conduct Periodic review of GxP systems.Exercises judgment in selecting methods, techniques, and evaluation criteria for obtaining results.Thorough understanding of FDA Quality System regulations in relation to computer system validation.Remains current on applicable regulations.

Education and Experience:

B.S. or equivalent in one of the following fields: Engineering or life science.Minimum 5-7  years’ experience in computer system validation in the life sciences industry.Previous experience supporting GxP computer system validation efforts including authoring computer system validation deliverables such as risk assessments, validation plans, test plans, test scripts and summary reports.Understanding of software development methodologies and concepts.Strong oral and written communication skills in English.Advanced proficiency in the use of MS Office suite.Strong skills at team facilitation, team organization, communication of priorities, and listening.Forward thinking mindset with the ability to hit the ground running and have ability to manage multiple priorities in a timely manner.Open to creative, innovative, flexible, and practical approaches to improving practices and solving problems.

Preferred Skills and Competencies:         

Experience in Agile methodology is preferred.Experience with application lifecycle management solution (Polarion) is a plus.Experience with CRM Salesforce application is preferred

NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 3 x/week; may work remotely other days). #LI-Hybrid