Quality Operations Senior Manager
4 settimane fa
Job Overview Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, OfficeJob Description Explore an outstanding opportunity at Thermo Fisher Scientific Inc. as a Pharmaceutical Development Services Quality Operations Senior Manager Join a world-class team at our Monza site, where we strive for flawless execution and aim to make a significant impact on a global scale.Primary responsibilities Manage reporting structure for Quality On The Floor and Quality Operations staff, ensuring accurate review of production, documentation, CoAs, and investigations in compliance with cGMPs, registration, and client needs.Act as the Qualified Person in product disposition and issues assessment.Guarantee adherence to corporate quality standards.Guarantee the surveillance of on-shift production activities (overlooking and fit&finish in production area), to proactively increase the Quality Culture within the Departments.Operations Ensure support to site operations to meet cGMP requirements and Corporate Standards.Facilitate efficient interactions with clients to ensure the respect of Quality Agreements and to develop business.Assist with operations performance reviews, identify issues, recommend solutions, and ensure follow-up.Compliance Aid in comparing gaps to GMP rules, updating guidelines, and planning corrective actions for GMP compliance.Support the site Regulatory Inspections to ensure that each inspection is accurately and effectively handled.Budget Assist the Supervisor with budget preparation, providing necessary data and proposals following corporate standards.Personnel and organization management Manage performance and development of collaborators to ensure achievement of personal and site goals as well as a "great place to work" environment.Lead the organization by setting goals, evaluating results, analyzing training needs to ensure commitment and motivation.Guarantee that both the initial and the continuous training of the department personnel are performed and is suited to the needs.Requirements Academic background in a chemical, scientific, or technical field such as Biology/Biotechnology, Chemistry, or Pharmacy.Validated experience in a similar position within a regulated environment such as pharmaceuticals or biotech.Highly preferable recognized by Regulatory Authority to act as Qualified Person (QP) per Article 49 of Directive 2001/83/EC.Expertise in GMP regulations (EU and US).In-depth knowledge of sterile injectable drug production processes.Experience with Pharma FDA-approved companies.Proficiency in MS Office (Minitab is a plus).Extensive experience with Pharmaceutical Quality Systems (e.g., Trackwise) and reporting tools.Excellent proficiency in English and Italian.Knowledge, Skills, Abilities Detailed understanding of pharmaceutical law, quality management systems, and QP duties, as well as deep understanding of manufacturing and supply chain processes.Experience in quality event management.Confirmed leadership skills with experience leading direct reports in a matrix complex organization.#J-18808-Ljbffr
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Quality Operations Senior Manager
17 ore fa
Monza, Italia Experteer Italy A tempo pienoJob OverviewWork Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, OfficeJob DescriptionExplore an outstanding opportunity at Thermo Fisher Scientific Inc. as a Pharmaceutical Development Services Quality Operations Senior Manager!Join a world-class team at our Monza site, where we...
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Quality Operations Senior Manager
1 settimana fa
Monza, Italia Experteer Italy A tempo pienoJob Overview Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office Job Description Explore an outstanding opportunity at Thermo Fisher Scientific Inc. as a Pharmaceutical Development Services Quality Operations Senior Manager! Join a world-class team at our Monza site, where we...
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Quality Operations Senior Manager
7 giorni fa
Monza, Italia Altro A tempo pienoJob OverviewWork Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office Job DescriptionExplore an outstanding opportunity at Thermo Fisher Scientific Inc. as a Pharmaceutical Development Services Quality Operations Senior Manager! Join a world-class team at our Monza site, where we...
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Senior Operations Manager
1 settimana fa
Monza, Italia Altro A tempo pienoTelepass Innova (società 100% controllata da Telepass che si occupa di sviluppare soluzioni innovative per il mercato della mobilità) cerca un Senior Operations Specialist che porti governance, metodo e velocità nell’esercizio dei sistemi di telepedaggio e dei servizi di mobilità digitale. La figura coordina attività operative E2E, governa incident e...
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Senior Operations Manager
4 settimane fa
Monza, Italia Altro A tempo pienoSenior Operations Manager – ERP & Special Projects and InitiativesBaker Hughes is seeking a Senior Operations Manager to lead ERP and digital transformation initiatives within supply chain processes. The role focuses on empowering operational excellence, aligning global supply chain processes, and driving technology adoption.ResponsibilitiesLead and manage...
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Senior Operations Manager
4 settimane fa
Monza, Italia Altro A tempo pienoSenior Operations Manager – ERP & Special Projects and Initiatives Baker Hughesis seeking a Senior Operations Manager to lead ERP and digital transformation initiatives within supply chain processes. The role focuses on empowering operational excellence, aligning global supply chain processes, and driving technology adoption.ResponsibilitiesLead and manage...
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Senior Operations Manager
2 settimane fa
Monza, Italia Altro A tempo pienoSenior Operations Manager – ERP & Special Projects and Initiatives Baker Hughesis seeking a Senior Operations Manager to lead ERP and digital transformation initiatives within supply chain processes. The role focuses on empowering operational excellence, aligning global supply chain processes, and driving technology adoption.ResponsibilitiesLead and manage...
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Senior Operations Manager
2 settimane fa
Monza, Italia Baker Hughes A tempo pienoSenior Operations Manager – ERP & Special Projects and InitiativesBaker Hughesis seeking a Senior Operations Manager to lead ERP and digital transformation initiatives within supply chain processes.The role focuses on empowering operational excellence, aligning global supply chain processes, and driving technology adoption.ResponsibilitiesLead and manage...
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Senior Operations Manager
2 settimane fa
Monza, Italia Baker Hughes A tempo pienoSenior Operations Manager – ERP & Special Projects and Initiatives Baker Hughes is seeking a Senior Operations Manager to lead ERP and digital transformation initiatives within supply chain processes. The role focuses on empowering operational excellence, aligning global supply chain processes, and driving technology adoption. Responsibilities Lead and...
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Senior Operations Manager
2 settimane fa
Monza, Italia Baker Hughes A tempo pienoSenior Operations Manager – ERP & Special Projects and Initiatives Baker Hughes is seeking a Senior Operations Manager to lead ERP and digital transformation initiatives within supply chain processes. The role focuses on empowering operational excellence, aligning global supply chain processes, and driving technology adoption. Responsibilities Lead and...
