Site Engagement Associate Director developing and overseeing oncology partnerships for clinical trials. Engaging with key sites to ensure high - quality and timely results in clinical research.
About the role
- Director of IT for Quality & Regulatory Systems at Insulet. Leading strategic planning and management of global systems that support Quality Assurance and Regulatory Affairs.
Responsibilities
- 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
- 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
- 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
- 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)
- 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
- 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
- Manage OPEX and CAPEX budgets for the team and assigned projects
- Contribute to long-range planning and resource forecasting at the program level
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
- Experience with Agile and Waterfall methodologies, and global team management
- Proven knowledge of the software and systems development life cycle.
- Knowledge of BI or AI platforms is a plus.
Benefits
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO)
- And additional employee wellness programs
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