Senior Staff Specialist, Quality eSystems

About the role

The Senior Staff Specialist, Quality eSystems is responsible for the strategic development, governance, and continuous improvement of global Quality Management System (QMS) electronic systems that support Regulatory Affairs and Quality functions. This role serves as a key business partner to Global Process Owners (GPOs), Divisional Process Owners (DPOs), and Enterprise Digital Technologies (EDT) to ensure enterprise systems are effective, compliant, scalable, and aligned with current and future business needs.

Responsibilities

• Serve as the Business System Owner and Subject Matter Expert (SME) for global Quality eSystems, supporting enterprise system governance, data management, and system integrations.
• Partner with Global Process Owners, Divisions, and Enterprise Digital Technologies to define, implement, and optimize enterprise system capabilities.
• Evaluate enterprise system interfaces and dependencies, ensuring integrations are documented, maintained, and escalated when issues arise.
• Drive initiatives that improve the efficiency, effectiveness, and compliance of global Quality Management System processes and technologies.
• Assess current and future business requirements and recommend system enhancements that support global operational needs.
• Support enterprise-wide projects, system implementations, validation activities, and achievement of key project milestones.
• Provide guidance on system changes required to support regulatory requirements, process improvements, and business transformation initiatives.
• Partner with stakeholders to develop training, governance, metrics, and communication strategies that promote compliant and effective eSystem usage.

Requirements

• Bachelor’s degree in Science, Engineering, Business, or a related discipline.
• Minimum 6 years of experience supporting global Quality Management Systems (QMS) or electronic systems.
• Experience working in a regulated medical device, pharmaceutical, biotechnology, or related industry.
• Experience supporting cross-functional, cross-site, or global projects.
• Knowledge of U.S. and international medical device regulations and quality system requirements.
• Experience supporting enterprise systems, system integrations, and business process optimization.
• Experience participating in quality audits, compliance activities, or validation processes.
• Experience working with Quality Management Systems within a regulated environment.

Preferred Qualifications

• Experience serving as a business system owner or subject matter expert for enterprise Quality systems.
• Experience partnering with Enterprise Digital Technologies or Information Technology organizations.
• Experience supporting global process ownership and enterprise business transformation initiatives.
• Experience developing training, system governance, and change management strategies.
• Experience supporting GxP-regulated systems and compliance requirements.
• Experience utilizing quality metrics and data-driven decision making.
• Experience working across multiple geographies and time zones.
• Formal project management training or experience leading enterprise system initiatives.