Job Title: Senior Manager – Quality & Regulatory Systems

Manager/Supervisor: Sr. Director, Information Technology

FLSA Status: Exempt

Position overview:                

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.

The Sr. Manager of IT for Quality & Regulatory Systems is a key member of Insulet’s Corporate Applications team, responsible for leading the strategic planning, implementation, and management of global systems that support Quality Assurance and Regulatory Affairs. This role ensures technology solutions are aligned with business objectives, compliant with regulatory standards, and scalable to support Insulet’s continued growth and global expansion.

The Sr. Manger will oversee a portfolio of validated applications, manage a high-performing global team, and collaborate cross-functionally with internal stakeholders and external partners to deliver innovative, efficient, and compliant systems. This role is instrumental in driving digital transformation across regulated business processes and enhancing operational excellence. As Insulet continues to grow our product range and expand into new geographies it is likely that current systems will be upgraded or replaced to support the strategic goals. The Senior Manager, IT Quality and Regulatory Systems will play a key role in building our teams to support these initiatives as well as participate in vendor selection and implementation of new technologies as we evolve

JOB / DUTIES / RESPONSIBILITIES

Oversee the lifecycle of validated systems including QMS platforms (e.g:Veeva systems, eDHR, content management, and labeling tools)Lead planning, execution, and governance of programs and projects, ensuring timely delivery and complianceManage risk, scope, and change across initiatives to maintain alignment with business goals

Team Leadership & Development

Lead and mentor a global team of managers and professionals, fostering a culture of accountability, collaboration, and continuous improvementDrive performance through coaching, feedback, and professional developmentPromote cross-functional teamwork and knowledge sharing across IT and business unitsRecruit, interview, hire, and onboard new staff in the department. Provide constructive and timely performance evaluations. Handle discipline and termination of employees in accordance with company policy.

Performance & Compliance

Develop and manage KPIs, scorecards, and performance analytics to drive operational efficiency and continuous improvementEnsure systems meet FDA, SOX, and other regulatory requirements, maintaining validated states and audit readinessChampion best practices in system design, governance, and delivery methodologies (Agile, Scrum, Kanban, Waterfall)

Stakeholder & Vendor Engagement

Build trust-based relationships with business partners through active listening and strategic alignmentManage vendor relationships, contracts, and third-party consultants to ensure quality and valueSupport IT intake processes and collaborate with Enterprise Architecture, Procurement, and Agile Delivery Office

Global Collaboration & Innovation

Work with global process owners to develop scalable, region-specific solutionsEvaluate third-party tools for feasibility and business impactContribute to product roadmaps and support geographic expansion strategies

Financial Oversight

Contribute to long-range planning and resource forecasting at the program level

Skills/Experience:  

Bachelor's degree, or equivalent experience10+ years of experience in the field including 5+ years supporting/managing QMS systems in the regulated environmentsWork closely with BPOs, technical leads, architects, and development teams to ensure that platforms are designed with scale and operability in mindTroubleshoot and debug complex issues in production applicationsAbility to analyze business processes, design process improvements, and train business users on the new processes.Ability to work independently & on multiple projects against deadlines.Communicate effectively with people at all levels of the organizationExperience with software development life cycle (SDLC) and agile/iterative methodologiesExperience in the healthcare, pharma or medical device industry a plus.

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

Additional Information:

The US base salary range for this full-time position is $141,000.00 - $211,500.00. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.

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!

At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

(Know Your Rights)