Manager, Quality (REMOTE)

Work Schedule

Environmental Conditions

Job Description

Position Summary

The Manager Quality serves as Thermo Fisher Scientifics 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 Scientifics 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 Scientifics 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

Experience

• 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 Commissioning & Qualification (C&Q) Process Validation Cleaning Validation Analytical Method Validation Analytical Instrument Qualification Validation lifecycle management.

• Experience implementing validation governance enterprise standards best practices or quality system improvements.

• Experience serving as a BPO system owner or process owner for enterprise quality or validation systems.

• Experience supporting regulatory inspections and responding to validation-related observations.

• Experience operating within a global highly matrixed organization supporting multiple Business Groups.

• Demonstrated success leading enterprise initiatives and influencing cross-functional stakeholders without direct reporting authority.

• Experience with Kneat ALM or equivalent enterprise validation platforms preferred.

Education

• Bachelors degree in Engineering Life Sciences Quality Regulatory Affairs Information Systems Computer Science or related technical discipline required.

• Advanced degree preferred.

• Professional certifications such as ASQ Lean Six Sigma Certified Validation Professional (CVP) CSV Quality or Regulatory certifications preferred.

Knowledge Skills & Abilities

• Expert knowledge of validation lifecycle principles across multiple validation disciplines.

• Strong understanding of ASTM E2500 GAMP 5 ISPE guidance Annex 11 21 CFR Part 11 and other applicable GxP regulations.

• Strong governance process management and continuous improvement skills.

• Experience with enterprise validation platforms and emerging technologies including AI-enabled software automation cloud platforms and digital quality systems.

• Ability to implement enterprise validation strategy through governance collaboration stakeholder engagement and business process ownership.

• Strong stakeholder management and influencing skills with the ability to lead through collaboration rather than formal authority.

• Excellent written verbal presentation facilitation and communication skills.

• Strong analytical critical thinking and problem-solving capabilities.

• Ability to translate complex validation concepts into practical guidance standards training and business solutions.