Manager, Quality (REMOTE)

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Position Summary The Manager, Quality serves as Thermo Fisher Scientific's enterprise validation subject matter expert responsible for implementing enterprise validation strategy through business process ownership, governance execution, harmonization, and capability development across the organization. Reporting to the Director, Global Quality, Digital & AI, this role supports enterprise validation activities across the full validation lifecycle, including computerized systems, equipment, facilities, utilities, commissioning, analytical instruments, cleaning, method, process, and other GxP validation disciplines. The position serves as Business Process Owner (BPO) for enterprise validation platforms, including Kneat and Application Lifecycle Management (ALM), provides Corporate Quality governance oversight for the Global IT Computerized Systems Validation (CSV) Program, and supports the Global Validation Council (GVC) as Thermo Fisher Scientific's enterprise Community of Practice, Center of Excellence, and Validation Academy. Working across Quality & Regulatory Affairs, IT, Engineering, Manufacturing, Regulatory Affairs, and Business Groups, this role partners with stakeholders to implement enterprise validation priorities, strengthen organizational capability, and improve consistency through practical, risk-based validation approaches. Location/Division Specific Information Preferred Hiring Locations: This role is open to anyone based in Europe Division: Corporate Quality & Regulatory Affairs (Corp Q&RA) How will you make an impact? You will: Execute enterprise validation initiatives that improve consistency and harmonization across Business Groups. Serve as Business Process Owner for enterprise validation platforms and drive their adoption, optimization, and continuous improvement. Strengthen validation compliance, inspection readiness, and governance through standardized validation practices. Support enterprise capability development through the Global Validation Council, Validation Academy, and Communities of Practice. Develop reusable validation guidance, templates, and best practices that improve efficiency and reduce duplication. Develop metrics and reporting that improve enterprise visibility into validation performance, risks, and opportunities. What will you do? 1. Enterprise Validation Strategy & Governance Serve as BPO for Kneat and ALM.   Provide Corporate Quality governance oversight for the Global IT CSV Program. Implement and continuously improve enterprise validation governance, standards, guidance, and best practices established by Corporate Quality. Execute enterprise validation harmonization initiatives across Business Groups while supporting business-specific requirements. Partner with Quality & Regulatory Affairs, IT, Engineering, Manufacturing, Regulatory Affairs, and Business Groups to implement enterprise validation priorities. Provide validation subject matter expertise supporting enterprise digital initiatives and emerging technologies, including AI-enabled quality solutions. 2. Enterprise Capability Development Support the GVC as Thermo Fisher Scientific's enterprise Community of Practice, Center of Excellence, and Validation Academy. Coordinate development of enterprise validation guidance, toolkits, standards, and knowledge-sharing resources. Facilitate Communities of Practice and enterprise working groups that support validation harmonization and capability development. Coordinate enterprise training, knowledge transfer, and capability-building initiatives that strengthen validation expertise across the organization. How will you get there?

8+ years of progressive experience in validation within FDA, ISO, or other regulated environments. Demonstrated experience across multiple validation disciplines, including several of the following: CSV, Equipment Qualification, Facility & Utility Qualification,