Senior Principal Specialist, QMS

The Senior Principal Specialist Quality eSystems is responsible for strategic leadership in development governance and continuous improvement of global Quality Management System (QMS) electronic systems that support regulatory compliance and business operations. This role partners with Quality Regulatory Affairs Enterprise Digital Technologies (EDT) Global Process Owners and cross-functional stakeholders to ensure enterprise systems are effective scalable compliant and aligned with current and future business needs.

What You Will Do

• Lead the strategic development implementation and continuous improvement of global QMS electronic systems.
• Partner with Quality Regulatory Affairs and Enterprise Digital Technologies teams to implement system enhancements and new functionality.
• Collaborate with enterprise system teams to identify and resolve process gaps redundancies and integration challenges across platforms.
• Ensure system interfaces dependencies and data flows are documented monitored and escalated when issues arise.
• Drive enterprise system improvement initiatives that increase operational efficiency compliance and user effectiveness.
• Manage enterprise system activities to support project milestones validation requirements and business objectives.
• Provide regulatory and quality systems expertise during internal audits external inspections and compliance assessments.
• Develop and deliver eSystem governance training metrics and reporting to support global adoption and GxP compliance.

What You Need

• Bachelors degree in Science Engineering Business or a related discipline.
• Minimum 10 years of experience working with enterprise Quality Management Systems (QMS) or electronic systems.
• Experience working in a regulated medical device pharmaceutical biotechnology or related industry.
• Experience leading cross-functional and multi-site system implementations or improvement projects.
• Knowledge of U.S. and international medical device regulations and quality system requirements.
• Experience supporting system validation activities and compliance documentation within a regulated environment.
• Experience with enterprise system integration governance and lifecycle management.
• Experience conducting or supporting internal and external quality audits.

Preferred Qualifications

• Experience supporting global Quality Management System platforms.
• Experience partnering with Enterprise Digital Technologies or Information Technology organizations.
• Experience leading large-scale enterprise transformation initiatives across multiple geographies.
• Experience with robotic automation AI and/or machine learning.
• Project management certification or formal project management experience.
• Experience developing quality metrics dashboards and performance reporting.
• Experience supporting system training and change management initiatives.
• Knowledge of GxP requirements and computerized system compliance.
• Experience working with global stakeholders across multiple time zones.