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Barrington James
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  • A growing clinical research organization is seeking a Clinical Researc... Read More
    A growing clinical research organization is seeking a Clinical Research Laboratory Manager (CLIA/GLP) to join the team. This position is central to the launch and ongoing operation of a new stand-alone clinical research safety laboratory built to support Phase I clinical studies. The right candidate will bring both technical expertise and leadership experience to ensure the lab meets the highest standards of quality and regulatory compliance. Key responsibilities include: Overseeing lab build-out, start-up, and day-to-day operations Managing personnel, QC/QA programs, and compliance activities (CLIA, GLP, GCP, IRB, OSHA) Developing SOPs, procedure manuals, and quality documentation Serving as the primary lab liaison for sponsors and internal clinical teams Managing assay validation, sample handling, and reference lab coordination Leading, mentoring, and evaluating laboratory staff Qualifications: BS degree required 3-5 years of early-phase clinical research lab experience MUST HAVE a Florida Supervisor License in all testing areas performed Solid working knowledge of CLIA, GLP, and GCP Proven leadership and communication skills Interested? Apply via the link below or send a direct message to learn more about the role and our clinical research mission. #ClinicalResearch #LaboratoryManager #CLIA #GLP #PhaseI #NowHiring Read Less
  • Senior Director Quality Assurance  

    - Santa Clara County
    *****EXCITING NEW OPPURTUNITY ****** Director/ Senior Director - Quali... Read More
    *****EXCITING NEW OPPURTUNITY ****** Director/ Senior Director - Quality Assurance We are partnered with a global biotech that is looking to expand their quality team by bringing in a director/senior director of quality assurance. Their position focus will be supporting the development, coordination and implementation of global pharmacovigilance regulations related to quality assurance activities. Key requirements- 8-10 years of hands-on Global Pharmacovigilance experience within biotech/pharma environments Proven track record supporting and leading FDA, EMA, and other global health authority inspections Confident interacting directly with regulators and managing regulatory inquiries Strong working knowledge of global GVP regulations and pharmaceutical quality standards Experienced in conducting internal audits and maintaining an effective, inspection-ready QMS Responsibilities- Ensure global PV compliance (FDA, EMA, ICH) Lead risk-based PV audits, CAPA management, and metric trending Drive inspection readiness and serve as QA lead during health authority inspections Oversee PV deviations and maintain effective quality systems documentation Provide PV training, regulatory updates, and cross-functional compliance support Support EU QPPV, reporting activities, and product complaint oversight Read Less
  • Senior Director Quality Assurance  

    - Santa Clara County
    *****EXCITING NEW OPPURTUNITY ****** Director/ Senior Director - Quali... Read More
    *****EXCITING NEW OPPURTUNITY ****** Director/ Senior Director - Quality Assurance We are partnered with a global biotech that is looking to expand their quality team by bringing in a director/senior director of quality assurance. Their position focus will be supporting the development, coordination and implementation of global pharmacovigilance regulations related to quality assurance activities. Key requirements- 8-10 years of hands-on Global Pharmacovigilance experience within biotech/pharma environments Proven track record supporting and leading FDA, EMA, and other global health authority inspections Confident interacting directly with regulators and managing regulatory inquiries Strong working knowledge of global GVP regulations and pharmaceutical quality standards Experienced in conducting internal audits and maintaining an effective, inspection-ready QMS Responsibilities- Ensure global PV compliance (FDA, EMA, ICH) Lead risk-based PV audits, CAPA management, and metric trending Drive inspection readiness and serve as QA lead during health authority inspections Oversee PV deviations and maintain effective quality systems documentation Provide PV training, regulatory updates, and cross-functional compliance support Support EU QPPV, reporting activities, and product complaint oversight Read Less

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