Quality Manager

🕒 vor 5 Tagen

🇬🇧 Vereinigtes Königreich – Remote

⏰ Vollzeit

🟠 Senior

🔴 Experte

👔 Manager

👻 Geisterscore 10%

Was es bedeutet: wie wahrscheinlich diese Stelle offen bleibt, ohne dass aktiv eingestellt wird.So liest du es: 60 % oder höher heißt, wir halten das für einen Geisterjob. Niedrigere Werte sind weniger bedenklich.Wie wir werten: Dauer offen, Neuveröffentlichungen, offene Stellen vs Teamgröße, wie schnell Stellen geschlossen werden, und ob ein Gehalt angegeben ist.Hinweis: eine Schätzung aus öffentlichen Daten, kein Urteil über das Unternehmen. Echte Stellen können hoch punkten, nutze es also als Hinweis, nicht als Fakt.

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Thermo Fisher Scientific

WebsiteLinkedInAlle Stellen

10.000+ Mitarbeiter

Gegründet 1956

🏥 Gesundheitswesen

📦 Logistik

🏭 Fertigung

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific ist der weltweite Marktführer im Dienste der Wissenschaft mit einem Jahresumsatz von mehr als 40 Milliarden US‑Dollar. Ihre Mission ist es, Kunden dabei zu unterstützen, die Welt gesünder, sauberer und sicherer zu machen – indem sie die lebenswissenschaftliche Forschung vorantreiben, komplexe analytische Herausforderungen lösen, die Produktivität in Laboren steigern und die Gesundheit von Patienten durch Diagnostik sowie die Entwicklung lebensverändernder Therapien verbessern. Mit einem globalen Team bietet das Unternehmen innovative Technologien und pharmazeutische Dienstleistungen über Marken wie Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon und PPD.

Beschreibung

• 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

🎯 Anforderungen

• 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

🏖️ Vorteile

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