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Compliance Adherence: Ensure strict site adherence to regulatory requirements, including implementing SOP's, US FDA Good Laboratory Practices (GLP), and current Good Manufacturing Practices (cGMP) under preclinical to clinical grade testing.
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Advanced knowledge of FDA, EMA, and GCP/GLP/GVP/ICH regulations and guidelines applicable for clinical trials conduct and/or regulated drug development activities, including general compliance and audit concepts; and.
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The candidate is also expected to support outsourcing efforts for designing, monitoring, execution and reporting of the nonclinical toxicology studies, have experience in managing regulatory-compliant toxicology studies in a CRO or biotechnology/pharmaceutical company, and have demonstrated understanding of GLP compliance and the relevant ICH & FDA guidance documents.
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We are looking for a professional with expertise in laboratory quality management systems (GCP, GLP), clinical Bioanalytics (mainly large molecules), pharmacokinetics, standard laboratory requirements, and familiarity with quality & information management systems.
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The Associate Director/Senior Manager of Clinical Quality will develop, manage, and improve existing quality systems to ensure appropriate controls for EyePoint in-house GCP and GLP capabilities.
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Ideal candidate will have broad experience in GCP/GLP environments, regulatory compliance and solid experience in GCP/GLP field auditing. Draft, review, revise or provide input to GCP/GLP SOPs to assess consistency and compliance with regulatory requirements/internal standards.
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Competent in ICH E6 (GCP/GLP/GCLP), ICH Q9, 21 CFR, GDPR and, HIPAA laws and regulations. Reviews clinical trial and non-human primate data ensuring integrity, privacy, consistency and compliance for multiple trials at a time.
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We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development.
$20 - $22 an hourExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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If applicable, ensure regulatory compliance (e.g., GLP & GCP) standards and policies for GxP products/services. With Research Informatics (RX), BR is making a strategic investment into informatics capabilities and is positioning itself to deliver the systems and services that are critical to the future of drug discovery.
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Conduct internal audits to assess effectiveness of Entrada's GCP/GLP QMS and process compliance including Clinical Study Report (CSR) and Trial Master File (TMF) audits. BS in a scientific discipline, advanced degree preferred with at least 10 years of experience in pharmaceutical / biotech / clinical research industry with significant experience in GCP/GLP environment.
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In-depth expertise in test method development, method qualification/transfer, and characterization of small-molecule drugs during preclinical (GLP toxicology) and early-phase clinical development.
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Regulatory Knowledge: Experience working within a GxP (GLP/GMP) environment is essential. This includes understanding concepts such as protein structure and function, enzyme kinetics, molecular biology techniques, and cellular signaling pathways.
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An understanding of clean room practice/cGMP and laboratory/GLP environments is required. Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA.
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Can streamline research by delivering operational and cost efficiencies through the strategic insourcing of GMP, GLP and non-GLP research services from discovery through safety assessment.
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Defines strategy for and oversees tactical execution strategic plan by direct reports to provide effective oversight of research, assay development in support of pre-clinical and clinical research, GLP animal studies, in vitro diagnostic development, and all R&D vendors.
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glp job in Boston, MA
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