Associate Director, Development Asset Quality, Daq
hace 3 meses
**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 managing business relationships with defined stakeholder groups and senior leaders in Development, Regulatory and Safety and for the strategic development and delivery of a GCP risk based robust quality management activities for these stakeholders. Director will be responsible for managing the Associate Directors/study quality leads including but not limited to providing mentoring, coaching, development etc.You will be responsible for: Assisting in the development of an overarching strategy related to proactive and sustainable quality and compliance for all programs/portfolio for assigned Therapeutic Area(s) (TAs)Where applicable, represent DAQ on Alexion Global Program Teams (GPTs) and Regulatory Strategy Teams (RSTs) to proactively identify critical to quality risks and mitigation strategy to drive excellence in study execution and to minimize risk to regulatory submission/approval.Work with cross functional and other 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 ManagementServe as the quality expert for global/systemic clinical quality issue investigations, which includes: In collaboration with issue owners lead Quality Event reportability assessments, investigations and Root Cause AnalysisPerform Quality Event risk assessments and trending (deviations, audit findings, inspection findings etc.) to determine robust CAPAsActs as quality approver for Quality Issues and CAPAs as assigned Be accountable for leading 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 complianceProvide 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 AreaServe as the Subject Matter Expert (SME) and provide guidance on major processes/platforms optimization and quality governance requirements where applicable e.g., TMF health oversight, CRO/Vendor oversight, medical device requirements etc. Drive continuous improvement and knowledge management by sharing case studies/lessons learned from QA activities to minimize recurrence of similar issuesActively participate in meetings driving quality and business performanceSupport Due Diligence and integration activities as assigned You will need to have: Bachelors degree in life science, or equivalent field, required Minimum of 8+ years of experience in clinical research area inclusive of, but not limited to, Good Clinical Practice or Good Clinical Practice quality assurance and complianceEstablished knowledge of GxP/GCP regulations and guidelines (EMA, FDA, PMDA etc.) Significant experience with GxP investigations, risk assessments and CAPA managementExperience participating in regulatory inspectionsFunctional planning experience and ability to develop functional vision, priorities and tacticsExperience with multinational products and regulations as well as with mandated risk management plansAbility to travel up to 10%The duties of this role are generally conducted in an office environment.
As is typical of an officebased role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and nonlinear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours. We would prefer for you to have: Advanced degree preferredCompetencies to be successful for this position include: Quality, process, and compliance orientedStrong interpersonal skills Critical thinkingIntegrityCommunicationTeamworkProblem solving
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Gr-369 | Associate Director, Development Asset Quality, Daq
hace 3 semanas
Barcelona, España Importante Empresa A tiempo completo.Associate Director, Development Asset Quality (DAQ)Location: BarcelonaThis 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 managing...
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Associate Director, Development Asset Quality
hace 7 días
Barcelona, Barcelona, España Importante Empresa A tiempo completoJob Title: Associate Director, Development Asset QualityAt Importante Empresa, we are seeking an experienced Associate Director, Development Asset Quality to join our team. As a key member of our Development Quality Team, you will drive Quality Culture with Development, Regulatory, and Safety stakeholders through learning, embedding a quality mindset, and...
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Associate Director, Development Asset Quality
hace 7 días
Barcelona, Barcelona, España Importante Empresa A tiempo completoJob Title: Associate Director, Development Asset QualityAt Importante Empresa, we are seeking an experienced Associate Director, Development Asset Quality to join our team. As a key member of our Development Quality Team, you will drive Quality Culture with Development, Regulatory, and Safety stakeholders through learning, embedding a quality mindset, and...
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Gr-369 | Associate Director, Development Asset Quality, Daq
hace 2 semanas
Barcelona, España Importante Empresa A tiempo completoAssociate Director, Development Asset Quality (DAQ)Location: BarcelonaThis 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 managing...
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Gr-369 | Associate Director, Development Asset Quality, Daq
hace 3 semanas
Barcelona, España Importante Empresa A tiempo completoAssociate 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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Gr-369 | Associate Director, Development Asset Quality, Daq
hace 3 semanas
Barcelona, España Importante Empresa A tiempo completoAssociate Director, Development Asset Quality (DAQ)Location: BarcelonaThis 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 managing...
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Associate Director, Development Asset Quality
hace 2 semanas
Barcelona, Barcelona, España Importante empresa A tiempo completoJob Title: Associate Director, Development Asset QualityJoin Importante empresa as an Associate Director, Development Asset Quality and drive quality culture with Development, Regulatory, and Safety stakeholders.About the Role:This is a unique opportunity to lead Quality Culture with Development, Regulatory, and Safety stakeholders through learning,...
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Associate Director, Development Asset Quality
hace 2 semanas
Barcelona, Barcelona, España Importante empresa A tiempo completoJob Title: Associate Director, Development Asset QualityJoin Importante empresa as an Associate Director, Development Asset Quality and drive quality culture with Development, Regulatory, and Safety stakeholders.About the Role:This is a unique opportunity to lead Quality Culture with Development, Regulatory, and Safety stakeholders through learning,...
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Associate Director, Development Asset Quality
hace 3 semanas
Barcelona, Barcelona, España Importante empresa A tiempo completoAbout the RoleWe are seeking a highly experienced Associate Director, Development Asset Quality to join our team at Importante empresa. As a key member of our Development Quality Team, you will play a critical role in driving Quality Culture with Development, Regulatory, and Safety stakeholders.Key ResponsibilitiesDevelop and execute a comprehensive quality...
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Associate Director, Development Asset Quality
hace 3 semanas
Barcelona, Barcelona, España Importante empresa A tiempo completoAbout the RoleWe are seeking a highly experienced Associate Director, Development Asset Quality to join our team at Importante empresa. As a key member of our Development Quality Team, you will play a critical role in driving Quality Culture with Development, Regulatory, and Safety stakeholders.Key ResponsibilitiesDevelop and execute a comprehensive quality...
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Associate Director, Development Asset Quality Lead
hace 2 semanas
Barcelona, Barcelona, España Importante Empresa A tiempo completoAbout the RoleWe are seeking a highly experienced Associate Director, Development Asset Quality to join our team at Importante Empresa. This is a key leadership position that will drive quality culture and excellence in our clinical development programs.Key ResponsibilitiesDevelop and implement quality strategies to ensure compliance with regulatory...
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Associate Director, Development Asset Quality Lead
hace 3 semanas
Barcelona, Barcelona, España Importante Empresa A tiempo completoAbout the RoleWe are seeking a highly experienced Associate Director, Development Asset Quality to join our team at Importante Empresa. This is a key leadership position that will drive quality culture and excellence in our clinical development programs.Key ResponsibilitiesDevelop and implement quality strategies to ensure compliance with regulatory...
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Director, Development Asset Quality Strategy
hace 2 semanas
Barcelona, Barcelona, España Dmar General Contracting & Development Inc. A tiempo completoJob SummaryDmar General Contracting & Development Inc. is seeking a highly skilled and experienced Director, Development Asset Quality Strategy to join our team. As a key member of our Development Quality Team, you will be responsible for driving Quality Culture with Development, Regulatory, and Safety stakeholders.Key ResponsibilitiesManage business...
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Director, Development Asset Quality Strategy
hace 2 semanas
Barcelona, Barcelona, España Dmar General Contracting & Development Inc. A tiempo completoJob SummaryDmar General Contracting & Development Inc. is seeking a highly skilled and experienced Director, Development Asset Quality Strategy to join our team. As a key member of our Development Quality Team, you will be responsible for driving Quality Culture with Development, Regulatory, and Safety stakeholders.Key ResponsibilitiesManage business...
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Senior Manager, Development Asset Quality
hace 3 semanas
Barcelona, España La Esperanza Child Development Center, Llc. 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 La Esperanza Child Development Center, Llc. 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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Director, Development Asset Quality Strategy
hace 2 semanas
Barcelona, España Dmar General Contracting & Development Inc. A tiempo completo.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 managing business relationships with defined clinical development stakeholder groups and senior leaders...
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Associate Director, Development Asset Quality and Excellence
hace 3 semanas
Barcelona, Barcelona, España Importante Empresa A tiempo completoAbout the Role:As a key member of the Development Quality Team at Importante Empresa, you will play a critical role in driving Quality Culture with Development, Regulatory, and Safety stakeholders. Your primary responsibility will be to manage business relationships with defined stakeholder groups and senior leaders in Development, Regulatory, and Safety,...
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Associate Director, Development Asset Quality and Excellence
hace 3 semanas
Barcelona, Barcelona, España Importante Empresa A tiempo completoAbout the Role:As a key member of the Development Quality Team at Importante Empresa, you will play a critical role in driving Quality Culture with Development, Regulatory, and Safety stakeholders. Your primary responsibility will be to manage business relationships with defined stakeholder groups and senior leaders in Development, Regulatory, and Safety,...
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Director, Development Asset Quality Strategy
hace 2 semanas
Barcelona, Barcelona, España Dmar General Contracting & Development Inc. A tiempo completoJob SummaryDmar General Contracting & Development Inc. is seeking a highly skilled and experienced Quality Director, Clinical Development to join our team. As a key member of our Development Quality Team, you will be responsible for driving Quality Culture with Development, Regulatory, and Safety stakeholders.Key ResponsibilitiesManage business relationships...
