Director of Global Supplier Quality Management at BioMarin focusing on successful supplier quality oversight and improvement. Leading digital advancements in supplier management while ensuring compliance and regulatory adherence.
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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