Senior Manager, Development Asset Quality
hace 3 días
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 supporting business relationships with defined stakeholder groups in Development, Regulatory and Safety and for the delivery of risk based GCP quality management activities for these stakeholders. You will be responsible for: Support the execution of the overarching strategy related to proactive and sustainable quality and compliance for all programs/portfolio for assigned Therapeutic Area(s) (TAs) Support quality partners to proactively identify study level Key Quality and Risk Indicators (KQIs/KRIs) and develops mechanisms of KQI/KRI, detection, oversight and trending with Clin development and Ops stakeholders and other stakeholders and functions such as Risk based Quality Management Support global/systemic clinical quality issue investigations, which includes: In collaboration with issue owners lead Quality Event reportability assessments, investigations and Root Cause Analysis Perform Quality Event risk assessments and trending (deviations, audit findings, inspection findings etc.) to determine robust CAPAs Acts as quality approver for Quality Issues and CAPAs as assigned Support inspection readiness for assigned programs/portfolio including but not limited to: Provide leadership and guidance to team members in promoting a culture of inspection readiness and sustainable clinical compliance Provide guidance to team members in Inspection Readiness and Preparation Activities (e.g., SME training, Mock inspection etc.) Support follow up and tracking of inspection commitment and effectiveness check for assigned programs/Therapeutic Area Support continuous improvement and knowledge management by sharing case studies/lessons learned from QA activities to minimize recurrence of similar issues Support in meetings driving quality and business performance You will need to have: Bachelor's degree in life science, or equivalent field, required Minimum of 6+ years of experience in clinical research area inclusive of, but not limited to, Good Clinical Practice or Good Clinical Practice quality assurance and compliance Established knowledge of GCP regulations and guidelines (EMA, FDA, PMDA etc.) Experience participating in regulatory inspections Strong collaborative, influencing and interpersonal skills – curious to understand business environment Ability to maintain and create professional networks with stakeholders Excellent communication skills; fluent oral and written English We would prefer for you to have: Advanced degree preferred Competencies to be successful for this position include: Quality, process, and compliance oriented Strong interpersonal skills Critical thinking Integrity Communication Teamwork Problem solving AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. #J-18808-Ljbffr
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Senior Manager, Development Asset Quality
hace 1 semana
Barcelona, Barcelona, España Alexion Pharmaceuticals,Inc. A tiempo completoThis 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 supporting business relationships with defined stakeholder groups in...
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Senior Manager, Development Asset Quality
hace 1 semana
Barcelona, Barcelona, España Alexion Pharmaceuticals A tiempo completoThis 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 supporting business relationships with defined stakeholder groups in...
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Senior Manager, Development Asset Quality
hace 2 meses
Barcelona, España Alexion Pharmaceuticals,Inc. A tiempo completoLocation: Barcelona, Spain Job reference: R-196671 Date posted: 04/05/2024 **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...
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Senior Manager, Development Asset Quality
hace 1 día
Barcelona, España Alexion Pharmaceuticals,Inc. A tiempo completoLocation: Barcelona, Spain Job reference: R-196671 Date posted: 04/05/2024 **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...
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Senior Manager, Development Asset Quality
hace 1 mes
Barcelona, España Alexion Pharmaceuticals A tiempo completoThis 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 supporting business relationships with defined stakeholder groups in...
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Senior Manager, Development Asset Quality
hace 3 semanas
Barcelona, España Alexion Pharmaceuticals A tiempo completoThis 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 supporting business relationships with defined stakeholder groups in...
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Associate Director, Development Asset Quality, Daq
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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Associate Director, Development Asset Quality, Daq
hace 2 semanas
Barcelona, España Alexion Pharmaceuticals,Inc. A tiempo completoSome opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and...
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Development Quality Manager, Hibrido
hace 4 semanas
Barcelona, España OXIGENT Technologies A tiempo completoDevelopment Quality Manager en hibrido. ¿Te interesaría seguir desarrollándote como Development Quality Manager en una multinacional alemana fabricante del sector automoción? Desde Oxigent Technologies seleccionamos un/a DEVELOPMENT QUALITY MANAGER para participar en el equipo de I+D siendo el responsable de monitorear y asegurar la calidad del...
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Development Quality Manager, Hibrido
hace 1 día
Barcelona, España OXIGENT Technologies A tiempo completoDevelopment Quality Manager en hibrido. ¿Te interesaría seguir desarrollándote como Development Quality Manager en una multinacional alemana fabricante del sector automoción? Desde Oxigent Technologies seleccionamos un/a DEVELOPMENT QUALITY MANAGER para participar en el equipo de I+D siendo el responsable de monitorear y asegurar la calidad del...
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Development Quality Manager, Hibrido
hace 1 semana
Barcelona, Barcelona, España Oxigent Technologies A tiempo completoDevelopment Quality Manager, hibrido Barcelona, Catalonia Development Quality Manager en hibrido.¿Te interesaría seguir desarrollándote como Development Quality Manager en una multinacional alemana fabricante del sector automoción?Desde Oxigent Technologies seleccionamos un/a DEVELOPMENT QUALITY MANAGER para participar en el equipo de I+D siendo el...
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Development Quality Manager, Hibrido
hace 1 semana
Barcelona, Barcelona, España Oxigent Technologies A tiempo completoDevelopment Quality Manager, hibrido Barcelona, Catalonia Development Quality Manager en hibrido.¿Te interesaría seguir desarrollándote como Development Quality Manager en una multinacional alemana fabricante del sector automoción?Desde Oxigent Technologies seleccionamos un/a DEVELOPMENT QUALITY MANAGER para participar en el equipo de I+D siendo el...
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Development Quality Manager
hace 1 semana
Barcelona, Barcelona, España Oxigent Technologies A tiempo completo¿Te interesaría seguir desarrollándote como Development Quality Manager en una multinacional alemana fabricante del sector automoción ?Desde Oxigent Technologies seleccionamos un/a DEVELOPMENT QUALITY MANAGER para participar en el equipo de I+D, siendo el responsable de monitorear y asegurar la calidad del desarrollo de los proyectos, ubicado en Vallès...
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Development Quality Manager, hibrido
hace 1 semana
Barcelona, Barcelona, España OXIGENT Technologies A tiempo completoDevelopment Quality Manager, hibrido Barcelona, Catalonia Development Quality Manager en hibrido.¿Te interesaría seguir desarrollándote como Development Quality Manager en una multinacional alemana fabricante del sector automoción?Desde Oxigent Technologies seleccionamos un/a DEVELOPMENT QUALITY MANAGER para participar en el equipo de I+D siendo el...
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Development Quality Manager, Hibrido
hace 1 semana
Barcelona, Barcelona, España OXIGENT Technologies A tiempo completoDevelopment Quality Manager en hibrido.¿Te interesaría seguir desarrollándote como Development Quality Manager en una multinacional alemana fabricante del sector automoción?Desde Oxigent Technologies seleccionamos un/a DEVELOPMENT QUALITY MANAGER para participar en el equipo de I+D siendo el responsable de monitorear y asegurar la calidad del desarrollo...
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Development Quality Manager, Hibrido
hace 1 semana
Barcelona, Barcelona, España Oxigent Technologies A tiempo completoDevelopment Quality Manager en hibrido. ¿Te interesaría seguir desarrollándote como Development Quality Manager en una multinacional alemana fabricante del sector automoción? Desde Oxigent Technologies seleccionamos un/a DEVELOPMENT QUALITY MANAGER para participar en el equipo de I+D siendo el responsable de monitorear y asegurar la calidad del...
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Asset Manager
hace 1 mes
Barcelona, España Inavitas A tiempo completoJob summary Ona Hotels & Apartments is looking for an Asset Manager to join their central officesNew position created due to company expansionSalary range: 35-40k Job seniority: mid-to-senior level Responsibilities • Reception, valuation, and analysis of new opportunities received• Proposal of asset improvement to increase performance and value•...
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Asset Manager
hace 4 semanas
Barcelona, España Inavitas A tiempo completoJob summary Ona Hotels & Apartments is looking for an Asset Manager to join their central officesNew position created due to company expansionSalary range: 35-40k Job seniority: mid-to-senior level Responsibilities • Reception, valuation, and analysis of new opportunities received• Proposal of asset improvement to increase performance and value•...
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Development Quality Manager
hace 1 semana
Barcelona, Barcelona, España Oxigent A tiempo completo¿Te interesaría seguir desarrollándote como Development Quality Manager en una multinacional alemana fabricante del sector automoción?Desde Oxigent Technologies seleccionamos un/a DEVELOPMENT QUALITY MANAGER para participar en el equipo de I+D, siendo el responsable de monitorear y asegurar la calidad del desarrollo de los proyectos, ubicado en Vallès...
