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

Insulet Corporation•San Diego, MA

13d•Hybrid

About The Position

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.

Requirements

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 stakeholder management skills
Experience with Agile and Waterfall methodologies, and global team management
Proven knowledge of the software and systems development life cycle.
Team leadership and management skills.
Self-sufficient, flexible, and motivated team player capable leading teams and managing several activities simultaneously.
Ability to work in a deadline focused, dynamic environment, and 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 on 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.

Nice To Haves

Knowledge of BI or AI platforms is a plus.
Experience in the healthcare, pharma or medical device industry a plus.

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