Scorpion Therapeutics
R&D Quality Lead - Site Redmond, travelling to Seattle, WA
Scorpion Therapeutics, Redmond, Washington, United States, 98052
Role Summary
R&D Quality Lead responsible for contributing to the development, implementation, and maintenance of Quality Management systems and activities for Just-Evotec Biologics (JEB) Product and Process Development. Ensures quality and regulatory requirements are met for GCP, GLP, GVP and site/vendor compliance with applicable GxP regulations; supports inspection readiness and risk mitigation in clinical trials. Responsibilities
Provide quality oversight for data generated by the product and process development (P&PD) function Partner with senior members of clinical and medical staff to develop plans for quality oversight of GCP and GVP activities Maintain strong relationships with multiple internal and external team members and cross functional groups Provide quality oversight to GCP/GLP/GVP vendors through vendor qualification and other appropriate quality oversight mechanisms as applicable Provide leadership for study team inspection readiness, and support GCP/GLP/GVP regulatory sponsor inspections globally Oversee/support the development of SOPs for internal GCP/GLP/GVP activities as well as monitoring and ensuring continuous improvement of these procedures/processes Input into planning of audits of systems and processes needed to support regulatory submissions Continuously assess compliance status of clinical programs/studies Perform quality document review and approval as required Assist with or provide GCP/GLP/GVP training for JEB employees as appropriate Oversee investigations of GCP/GLP/GVP related quality issues, deviations, and root cause investigations. Collaborate with GCP/GLP/GVP functions to identify, assess, and determine effectiveness of CAPAs and manage and approve completion of CAPAs Conduct internal compliance metrics analyses and risk assessments related to functional area responsibilities and report to management as appropriate Provide input to and support for Quality Management Review Travel to JEB local and international sites as required Qualifications
Bachelor's degree Life/Health Sciences and/or master's degree; a plus Minimum 7 years of leadership experience 12 plus years' experience in clinical quality assurance or clinical operations background, in a regulated biotechnology, pharmaceutical or diagnostics industry environment Knowledge of FDA, EMA and MHRA regulations and guidelines regarding GCP required. GLP and GVP preferred Knowledge of QMS and CAPA related processes and systems is required Ability to work across GCP/GLP/GVP functional areas and foster a collaborative culture of quality within the organization Experience with NDA and/or BLA submissions and Inspection readiness for Sponsors, clinical sites and vendors is strongly desired Must have applied experience in quality assurance auditing and applicable regulations Skills
Quality Oversight GCP/GLP/GVP Knowledge Regulatory Submissions and Inspection Readiness CAPA and Risk Management Vendor Quality Oversight Cross-functional Collaboration Education
Bachelor's degree in Life/Health Sciences; Master's preferred Additional Requirements
Travel to JEB local and international sites as required
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R&D Quality Lead responsible for contributing to the development, implementation, and maintenance of Quality Management systems and activities for Just-Evotec Biologics (JEB) Product and Process Development. Ensures quality and regulatory requirements are met for GCP, GLP, GVP and site/vendor compliance with applicable GxP regulations; supports inspection readiness and risk mitigation in clinical trials. Responsibilities
Provide quality oversight for data generated by the product and process development (P&PD) function Partner with senior members of clinical and medical staff to develop plans for quality oversight of GCP and GVP activities Maintain strong relationships with multiple internal and external team members and cross functional groups Provide quality oversight to GCP/GLP/GVP vendors through vendor qualification and other appropriate quality oversight mechanisms as applicable Provide leadership for study team inspection readiness, and support GCP/GLP/GVP regulatory sponsor inspections globally Oversee/support the development of SOPs for internal GCP/GLP/GVP activities as well as monitoring and ensuring continuous improvement of these procedures/processes Input into planning of audits of systems and processes needed to support regulatory submissions Continuously assess compliance status of clinical programs/studies Perform quality document review and approval as required Assist with or provide GCP/GLP/GVP training for JEB employees as appropriate Oversee investigations of GCP/GLP/GVP related quality issues, deviations, and root cause investigations. Collaborate with GCP/GLP/GVP functions to identify, assess, and determine effectiveness of CAPAs and manage and approve completion of CAPAs Conduct internal compliance metrics analyses and risk assessments related to functional area responsibilities and report to management as appropriate Provide input to and support for Quality Management Review Travel to JEB local and international sites as required Qualifications
Bachelor's degree Life/Health Sciences and/or master's degree; a plus Minimum 7 years of leadership experience 12 plus years' experience in clinical quality assurance or clinical operations background, in a regulated biotechnology, pharmaceutical or diagnostics industry environment Knowledge of FDA, EMA and MHRA regulations and guidelines regarding GCP required. GLP and GVP preferred Knowledge of QMS and CAPA related processes and systems is required Ability to work across GCP/GLP/GVP functional areas and foster a collaborative culture of quality within the organization Experience with NDA and/or BLA submissions and Inspection readiness for Sponsors, clinical sites and vendors is strongly desired Must have applied experience in quality assurance auditing and applicable regulations Skills
Quality Oversight GCP/GLP/GVP Knowledge Regulatory Submissions and Inspection Readiness CAPA and Risk Management Vendor Quality Oversight Cross-functional Collaboration Education
Bachelor's degree in Life/Health Sciences; Master's preferred Additional Requirements
Travel to JEB local and international sites as required
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