Senior Staff Specialist, Quality eSystems

The SeniorStaffSpecialist QualityeSystemsis responsible forthe strategicdevelopment 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.

What You Will Do

• Serve as the Business System Owner and Subject Matter Expert (SME) for global QualityeSystems supporting enterprise system governance data management and system integrations.
• Partner with Global Process Owners Divisions and Enterprise Digital Technologies to define implement andoptimizeenterprise system capabilities.
• Evaluate enterprise system interfaces and dependencies ensuring integrations are documentedmaintained 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 changesto support regulatory requirements process improvements and business transformation initiatives.
• Partner with stakeholders to develop training governance metrics and communication strategies that promote compliant and effectiveeSystemusage.

What You Need

• Bachelors degree in Science Engineering Business ora relateddiscipline.
• Minimum6years of experience supporting global Quality Management Systems(QMS)orelectronic 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.
• Experienceparticipatingin 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 supportingGxP-regulated systems and compliance requirements.
• Experienceutilizingquality metrics and data-driven decision making.
• Experience working across multiple geographies and time zones.
• Formal project management training or experience leading enterprise system initiatives.