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Associate Director, Quality Assurance
hace 4 días
.Associate Director, Quality Assurance Barcelona, Catalonia Associate Director, Quality AssuranceBarcelonaBarcelona, Catalonia, ES We are Growing Let us support your career journey the Biorasi way. Innovative, Collaborative, Dynamic and Evolving. Capitalizing on your strengths while encouraging work-life balance. Biorasi is an award-winning, customer-focused, full-service clinical research organization.Biorasi is looking for top performers who are as passionate about clinical research as we are – clinical trial veterans and industry newcomers who will thrive in our fast-paced environment and help us drive new therapies to patients. Here is your chance to become a vital part of a growing global company in the expanding clinical research industry.Your role:Lead development, implementation, and maintenance of GCP Quality Systems and SOPsTrain and mentor staff on global GCP regulations and guidance.Provide QA oversight and auditing of eTMFsLead and/or oversee consultant mediated audits; develop, recommend, andfollow up on corrective actionsLead preparations for Clinical Operations (corporate and third-party) inspection-readinessLead and manage GCP Inspections on behalf of Biorasi and Biorasi clients.Serve as an SME for areas of responsibility during regulatory inspections, and directly manage inspection Ready -Room activities.In partnership with the Clinical Operations, Regulatory, and Pharmacovigilance teams, design and implement a risk-based clinical Quality Assurance management systemIdentify QA and compliance related issues and implement solutions to ensure timelines are maintainedEstablish metrics and report the state of GCP Quality and compliance of clinical trials to senior managementEnsure Clinical Operations activities are compliant with cGCP, cGLP, FDA, ICH, EMA regulations and guidelines and industry standardsProvide consultation in interpretation of regulations/guidelines, as they apply to GCP practice, awareness of regional regulatory requirement, and phase of study andKeep abreast of industry developments – forthcoming regulations, guidance, best practices, etc.Ensures that Biorasi quality systems, processes, and procedures are compliant with applicable regulations and ICH guidelines.Ensures that Biorasi standard operating procedures (SOPs) are compliant with applicable regulations and guidelines.Oversees the planning and conduct of internal, investigator, and vendor Quality Assurance audits.Manages the administration of Quality Assurance files and the control of central files.Your Profile:Degree in biomedical sciences, related scientific discipline.10+ years in drug development or clinical research within the pharmaceutical industry or CRO with at least three years in quality assurance, quality management, or clinical safety related area of responsibility.Strong planning, leadership, negotiation, communication, and presentation skills.Experienced with auditing clinical vendors and investigator sites
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Associate Director Audit Quality Assurance
hace 1 semana
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Associate Director Labs/audit Quality Assurance
hace 3 semanas
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hace 2 meses
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Director, Labsqa/audit Quality Assurance, R&d
hace 2 días
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Quality Assurance Specialist
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Barcelona, Barcelona, España Startops A tiempo completoQuality Assurance Specialist (French Bilingual) Implement and manage global Quality Assurance tools and processes within the French BPO Partner networkLocation:Barcelona Job Tags: Procurement & Production About The Role - Implement and manage global Quality Assurance tools, processes, and performance within the French BPO Partner network - Partner with...
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hace 4 semanas
Barcelona, España AstraZeneca A tiempo completo**Associate Director, Development Asset Quality (DAQ)Location**: Barcelona This is what you will do: As part of the Development Quality Team you will drive Quality Culture with Development, Regulatory and Safety stakeholders, through learning, embedding a quality mindset, and executing on continuous improvement opportunities. You will be responsible for...
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Barcelona, España AstraZeneca A tiempo completo**Associate Director, Development Asset Quality (DAQ)Location**: Barcelona This is what you will do: As part of the Development Quality Team you will drive Quality Culture with Development, Regulatory and Safety stakeholders, through learning, embedding a quality mindset, and executing on continuous improvement opportunities. You will be responsible for...
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Quality Assurance Manager:Barcelona
hace 1 semana
Barcelona, España Buscojobs ES C2 A tiempo completoEstoy trabajon un centro tecnologico en Barcelona y buscan a un Quality Assurance Manager para uno de sus nuevos proyectos, el proyecto es bastante interesante y trabaja con terapias avanzadas y en el que ademas de haber muy buen ambiente y buena carga de trabajo todos los empleados estan muy contentos. La vacante es indefinida y office based en Barcelona y...
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Quality Assurance Manager
hace 3 días
Barcelona, España Bion - Bioconservacion A tiempo completoCompany DescriptionBIOCONSERVACION, founded in 1996, is a reliable manufacturer of air filtration and gas purification solutions. We deliver innovative air filtration solutions to meet clients' unique needs across different industries. We help our customers to be more successful through innovative gas filtration solutions that add value to their business....
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Quality Assurance Manager
hace 3 días
Barcelona, España Bion - Bioconservacion A tiempo completoCompany DescriptionBIOCONSERVACION, founded in 1996, is a reliable manufacturer of air filtration and gas purification solutions. We deliver innovative air filtration solutions to meet clients' unique needs across different industries. We help our customers to be more successful through innovative gas filtration solutions that add value to their business....
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Quality Assurance Manager
hace 3 días
Barcelona, España Bion - Bioconservacion A tiempo completoCompany Description BIOCONSERVACION, founded in 1996, is a reliable manufacturer of air filtration and gas purification solutions. We deliver innovative air filtration solutions to meet clients' unique needs across different industries. We help our customers to be more successful through innovative gas filtration solutions that add value to their business....
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Quality Assurance
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hace 2 semanas
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O904 | Program Manager
hace 2 semanas
Barcelona, España Talent Search People A tiempo completoWe are looking for an Program Manager- Quality Assurance to collaborate with an important client in the insurance sector.- Experience in the IT industry, with a strong focus on Quality Assurance or Project Management or Program Manager within IT transformation projects.- Degree in Computer Science, Information Technology, Business Administration, or a...