Quality Manager

🔥 0 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

👔 Manager

👻 Ghost score 10%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Execute enterprise validation initiatives that improve consistency and harmonization across Business Groups • Serve as Business Process Owner for enterprise validation platforms and drive 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 to improve efficiency and reduce duplication • Develop metrics and reporting to improve enterprise visibility into validation performance, risks, and opportunities • Serve as BPO for Kneat and ALM • Provide Corporate Quality governance oversight for the Global IT Computerized Systems Validation Program • Implement and continuously improve enterprise validation governance, standards, guidance, and best practices established by Corporate Quality • Execute 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 for enterprise digital initiatives and emerging technologies, including AI-enabled quality solutions • Support the Global Validation Council as an 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 • Coordinate enterprise training, knowledge transfer, and capability-building initiatives

🎯 Requirements

• 8+ years of progressive experience in validation within FDA, ISO, or other regulated environments • Experience across multiple validation disciplines, including CSV, Equipment Qualification, Facility & Utility Qualification, Commissioning & Qualification (C&Q), Process Validation, Cleaning Validation, Analytical Method Validation, Analytical Instrument Qualification, and 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 in 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 • Bachelor's 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 • 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 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

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule