Director, IT – QMS and R&D Systems (Hybrid)

Position Summary

The Director 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 (QMS), Regulatory Affairs, and Post-Market Surveillance and R&D Systems. 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 Director 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 expand its product portfolio and enter new global markets, we anticipate the need to upgrade or replace existing systems to support our strategic growth. The Director of QMS and R&D Systems will be instrumental in shaping and scaling teams to support these transformation initiatives.

This role will actively contribute to vendor evaluation, selection, and the implementation of new technologies that align with our evolving business needs. We are seeking a visionary leader who can help modernize our systems and drive excellence across quality and regulatory functions in a dynamic, fast-paced environment.

Key Responsibilities

Strategic Leadership & Business Alignment

• Partner with business leaders to align IT strategies with R&D, Quality, Regulatory, and Post-Market priorities

• Translate business needs into actionable technology roadmaps and solutions

• Serve as a trusted advisor and provide thought leadership on emerging technologies, vendor capabilities, and industry trends

Application & Program Management

• Oversee the lifecycle of validated systems including QMS platforms (e.g., TrackWise), Veeva systems, Polarion, eDHR, content management, and labeling tools

• Lead planning, execution, and governance of programs and projects, ensuring timely delivery and compliance

• Manage 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 improvement

• Drive performance through coaching, feedback, and professional development

• Promote cross-functional teamwork and knowledge sharing across IT and business units

Performance & Compliance

• Develop and manage KPIs, scorecards, and performance analytics to drive operational efficiency and continuous improvement

• Ensure systems meet FDA, SOX, and other regulatory requirements, maintaining validated states and audit readiness

• Champion 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 alignment

• Manage vendor relationships, contracts, and third-party consultants to ensure quality and value

• Support 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 solutions

• Evaluate third-party tools for feasibility and business impact

• Contribute to product roadmaps and support geographic expansion strategies

Financial Oversight

• Manage OPEX and CAPEX budgets for the team and assigned projects

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

Qualifications

• Bachelor’s degree in Computer Science, Information Systems, or related field (Master’s preferred)

• 10+ years of IT experience, with 5+ years in leadership roles supporting regulated environments as well as International experience is strongly desired

• 3+ years of experience managing a team of senior managers or managers

• Proven expertise in Quality, Regulatory and R&D systems within the medical device or any other regulatory controlled industry.

• Strong understanding of GxP, validation, and compliance frameworks

• Exceptional communication, leadership, and st