Quality Issue Lead
hace 2 semanas
Mexico, Remote**Additional Locations**: Argentina-Remote; Brazil-Remote**Job ID** R **Category** Quality Management**ABOUT THIS ROLE**:The Issue Lead will be responsible for driving QE case management, ensuring that investigations are conducted thoroughly within timelines and compliance requirements, overseeing the efficiency of the process by which the Sponsor conducts GCP investigations, and leveraging data to assess the efficiency / performance of the appropriate teams to perform interventions as needed.The Issue Lead will also triage submitted cases to ascertain if the Quality Event (QE) threshold has been met and assess cases to determine if they need expedited reporting to senior management and/regulatory authorities and be accountable for managing confirmed Quality Event (QE) case through the investigation process including root cause analysis.**Quality Event Assessment and Investigation**:This individual will be accountable for the review and classification of submitted quality issues to ascertain if the QE threshold has been met. He or she will ensure that each submitted issue is reviewed based on the established criteria, is categorized appropriately, and completed within the required time frame to ensure that events are appropriately qualified enabling expedited investigation where necessary. This individual will also be responsible for completing the necessary documentation in the QMS system regarding the assessment of the submitted events.**Notification to Management**:This individual will be responsible for initiating appropriate escalation of Critical QEs when necessary, ensuring that management is promptly and appropriately informed of quality events. The Issue Lead will be required to assess critical issues and identify these items as appropriate for escalation to leadership via the Notification to Management process.**Root Cause Analysis / Gap Analysis / Due Diligence**:**Process Analysis and Improvement**:This individual will be responsible for contributing to process development and improvement for case management including contributing to the development of technology to enable the process. In addition, the individual, along with Senior Issue Lead peers, will develop and implement guidance documents and training to assist the investigation leads in completing cases to expectations.**CAPA Plan Development and Management**:This individual will hold accountability for ongoing monitoring of CAPA completion and tracking of effectiveness for implemented mitigation actions to ensure they are working as expected—for quality events, inspections and audits- Ensure implementation of QE / audit / inspection CAPAs and remediation plans- Track effectiveness checks and report on trends**Risk Mitigation Tracking**Track and ensure implementation of risk mitigations and evaluate potential impacts to business.**Education**:BS - 7+ years or equivalentMS/MBA - 6+ years or equivalent**Experience**:- Minimum of 5 years of pharmaceutical experience with solid experience in data management, operational aspects, GCP Quality, GxP Quality, and/or regulatory- Regulatory inspection experience- Process and system management experience- Detailed knowledge of clinical trial processes and relationships required- Knowledge of GCP requirements and applicable SOPs and regulations- Project management, administrative, and technical capabilities are required, as well as effective verbal and- Strong background in continuous improvement methodology (i.e., Lean Six Sigma) preferred.LI-REMOTE
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Quality Issue Lead
hace 2 semanas
Desde casa, México Parexel A tiempo completoMexico, Remote **Additional Locations**: Argentina-Remote; Brazil-Remote **Job ID** R0000034485 **Category** Quality Management **ABOUT THIS ROLE**: The Issue Lead will be responsible for driving QE case management, ensuring that investigations are conducted thoroughly within timelines and compliance requirements, overseeing the efficiency of the process...
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Project Quality
hace 3 semanas
Desde casa, México Parexel A tiempo completo**Job Purpose**:Partner with operational delivery teams focusing on first-time quality, robust risk and issue management and maintaining an inspection-ready state. Provide quality expertise through the execution of quality SOPs to support operations, leadership and clients.**What you´ll do**:- Analyze key risk indicators and investigate risk signals by...
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Project Quality
hace 3 semanas
Desde casa, México Parexel A tiempo completo**Job Purpose**:Partner with operational delivery teams focusing on first-time quality, robust risk and issue management and maintaining an inspection-ready state. Provide quality expertise through the execution of quality SOPs to support operations, leadership and clients.**What you´ll do**:- Analyze key risk indicators and investigate risk signals by...
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Project Quality and Risk Lead
hace 2 días
Desde casa, México Parexel A tiempo completoMexico, Remote **Additional Locations**: Bogota, Colombia; Buenos Aires, Argentina; Lima, Lima, Peru; Santiago, Region Metropolitana de Santiago, Chile; Sao Paulo, São Paulo, Brazil **Job ID** R0000022782 **Category** Quality Management **ABOUT THIS ROLE**: The **Project Quality and Risk Lead** assumes the lead (with support of LM or Mentor) of Quality...
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Production Quality Management Supervisor
hace 2 semanas
Desde casa, México LeadVenture A tiempo completo**Production Quality Management Supervisor(**:**Job Overview**:**Key Responsibilities**:- ** Quality Assurance Leadership**: Lead the QA team in developing and executing comprehensive test strategies for web-based projects, ensuring all features are thoroughly tested across browsers and devices.- ** Process Improvement**: Continuously refine QA processes,...
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Production Quality Management Supervisor
hace 2 semanas
Desde casa, México LeadVenture A tiempo completo**Production Quality Management Supervisor(**: **Job Overview**: **Key Responsibilities**: - ** Quality Assurance Leadership**: Lead the QA team in developing and executing comprehensive test strategies for web-based projects, ensuring all features are thoroughly tested across browsers and devices. - ** Process Improvement**: Continuously refine QA...
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H - Edi Developer
hace 2 días
Desde casa, México Invest in Quality A tiempo completoFecha de publicación: 13 Enero 2025 The Developer’s main responsibility is to analyze, design and develop an accurate quality EDI solution within defined timelines based on the specific customer requirements. - Lugar: - México - Remote - Skills: - Development, Quality and Testing - Work closely with Business Analyst to deliver quality solution. -...
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Product Quality Engineer
hace 4 semanas
Desde casa, México Google A tiempo completoNote: Google’s hybrid workplace includes remote roles.**Remote location: Mexico.****Minimum qualifications**:- Bachelor's degree in Mechanical Engineering, Industrial Engineering, Material Engineering, a related field, or equivalent practical experience.- 5 years of experience working in computing hardware quality, product engineering, or electronic...
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Clinical Quality Compliance Specialist
hace 3 semanas
Desde casa, México ICON A tiempo completoAs a Clincial Quality Compliance Lead you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.**What you will be doing**:- Under the leadership of the Operations Quality Lead, develop, contribute, and support facilitation, presentation, and communication of GCP Lessons Learned, GCP...
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Rwe Associate Clinical Operations Lead
hace 1 semana
Desde casa, México IQVIA A tiempo completo**Associate Clinical Operations Lead** **Essential Functions**: - Oversee the delivery of Site Management project tasks, providing advice and guidance to achieve high performance and quality project deliverables. - Ensure overall project efficiency and adherence to project timelines and financial goals; report metrics and out of scope activities. -...
