Quality Manager

🕒 il y a 8 jours

🇬🇧 Royaume-Uni – Télétravail

⏰ Temps Plein

🟠 Senior

🔴 Expert

👔 Manager

👻 Score fantôme 10%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Thermo Fisher Scientific

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1956

🏥 Santé

📦 Logistique

🏭 Fabrication

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific est le leader mondial dans le service aux sciences, avec un chiffre d'affaires annuel de plus de 40 milliards de dollars. Leur mission est de permettre à leurs clients de rendre le monde plus sain, plus propre et plus sûr en soutenant la recherche en sciences de la vie, en résolvant des défis analytiques complexes, en augmentant la productivité des laboratoires et en améliorant la santé des patients grâce aux diagnostics et au développement de thérapies révolutionnaires. Avec une équipe mondiale, ils offrent des technologies innovantes et des services pharmaceutiques à travers des marques telles que Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon et 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

🎯 Exigences

• 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

🏖️ Avantages

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