739 clinical quality assurance jobs at 474 companies in United States
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Director, Clinical Quality Assurance (GCP)
Jersey City or Millbrae
$204k-$247k/yrHybridFull Time
Eikon TherapeuticsNASDAQ: EIKN: Discovers drugs using advanced live-cell imaging and protein tracking.
12+ YOE12+ years clinical quality assurance experience (or 10+ with advanced degree), expert GCP/ICH E6(R2) knowledge, audit and inspection experience, leadership skills, and ability to travel up to 50%.
WEP Clinical: Manages clinical trial services and early patient access programs.
5+ YOE2+ MgmtBachelor's degree required; 5-7 years in clinical quality, 2-3 years of leadership preferred, regulated clinical experience, global trials, audits, CAPAs, risk assessments, eQMS, eTMF, and regulatory knowledge.
Jazz PharmaceuticalsNASDAQ: JAZZ: Biopharmaceutical developing therapies for neuroscience and oncology.
14+ YOERequires 14+ years in pharmaceutical or biotechnology industries, clinical quality and GCP compliance expertise, audit and risk management experience, and a science-related bachelor's degree; master's or PhD preferred.
Clay Consulting: Conducts diagnostic medical and audiology exams for military veterans.
Requires a nursing license, medical knowledge, strong English communication, computer proficiency, accurate independent work, confidentiality, and quality assurance skills; 40 WPM typing preferred.
Microsoft Word, Microsoft Outlook, Microsoft Excel, Internet
BrioHealth Solutions: Developing advanced mechanical circulatory support systems for heart failure.
8+ YOEBachelor's degree in a relevant discipline and 8+ years in clinical quality, operations, or research within medical devices. Requires FDA IDE trial, GCP audits, CAPA, investigations, and risk-based quality experience.
Clinical Quality Management System (CQMS), Good Clinical Practice (GCP), ISO 14155, Clinical Quality Management Systems (CQMS), FDA Bioresearch Monitoring (BIMO)
8+ YOERequires 8+ years of clinical research experience, knowledge of GCP quality systems, complex investigations, root cause analysis, CAPA, and a BS/BA in science or related field or equivalent experience.
Boston ScientificNYSE: BSX: Developer and manufacturer of innovative medical devices and therapies.
5+ YOEBachelor's degree, 5+ years clinical QA experience including GCP audits, working knowledge of ISO 14155/13485/GCP/GMP/GDP, CAPA and quality systems experience, ability to travel up to 30%.
ISO 14155, ISO 13485, Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Documentation Practice (GDP)
North Chicago or Irvine or South San Francisco or Worcester or Dublin or Maidenhead
$125k-$237k/yrHybridFull Time
AbbVieNYSE: ABBV: Develops and sells innovative pharmaceutical and biopharmaceutical medicines.
5+ YOEBachelor's in a physical/life science, nursing, pharmacy or equivalent; 5+ years pharmaceutical industry experience in GCP quality/regulatory/clinical operations; 1+ years GCP QA auditing preferred; strategic leadership and problem-solving skills; global regulations knowledge.
Boston ScientificNYSE: BSX: Developing and manufacturing innovative medical devices for less-invasive treatments.
3+ YOEBachelor's in science/health/engineering, 3+ years with quality systems and controlled processes, ability to travel up to 30%, knowledge of GCP/ISO 14155 preferred, audit experience and quality certifications preferred.
Boston ScientificNYSE: BSX: Manufacturer of interventional medical devices and technologies.
3+ YOEBachelor's degree in science/health/engineering, minimum 3 years with quality systems and controlled processes, ability to travel up to 30%, knowledge of GCP/ISO 14155 preferred, auditing and quality certification experience preferred.
Artiva BiotherapeuticsNASDAQ: ARTV: Develops allogeneic natural killer cell-based therapies for various diseases.
6+ YOEBS/BA in scientific field,6+ years clinical/QA experience,3+ years Clinical QA,knowledge of ICH-GCP/CLIA/CLIP/CAP,inspection and audit experience,investigations and CAPA,Microsoft Word/Project/Excel.
Microsoft Word, Microsoft Project, Microsoft Excel
Merck & Co.NYSE: MRK: Develops and manufactures prescription medicines, vaccines, and animal health products.
Bachelor's degree or above in clinical medicine, life science, or pharmacy; clinical development and regulatory expertise; quality assurance, auditing, GxP, risk assessment, and stakeholder management skills.
Arrowhead PharmaceuticalsNASDAQ: ARWR: Develops RNAi medicines to treat genetic and intractable diseases.
3+ YOEBachelor's in science,3+ years regulated industry experience with QA/auditing/GCP exposure,2 years GCP quality oversight,knowledge of FDA/ICH/European regs,Veeva and Microsoft Office proficiency.
Veeva, Microsoft Word, Microsoft PowerPoint, Microsoft Excel
Vera TherapeuticsNASDAQ: VERA: Develops treatments for serious immunological and autoimmune diseases.
8+ YOEBachelor's in life sciences/pharmacy required (advanced degree preferred), ~8+ years industry experience with leadership in clinical quality, strong knowledge of GxP (GCP, GVP, GLP), experience with CAPA, audits, inspection readiness, and QMS practices; relevant certifications a plus.
Quest DiagnosticsNYSE: DGX: Provides clinical laboratory diagnostic testing and health information services.
3+ YOEBachelor's degree in medical technology, chemical, biological, or clinical laboratory science; 3+ years of laboratory regulatory and quality assurance experience; Microsoft Office skills; Lean Six Sigma preferred.
Microsoft Office, Microsoft Excel, Microsoft Access, MediaLab, SmartSolve, Radar, CAP, SDS, JHA
LabcorpNYSE: LH: Provides clinical laboratory testing and drug development services globally.
2+ YOEBachelor’s degree in chemical, biological, clinical laboratory science, or medical technology; 2+ years as a medical technologist or in quality assurance; laboratory regulations and audit knowledge; strong analytical and computer skills.
Microsoft Office, Document Control system, 5S, CAP, CLIA, ISO
GRO Community: Mental health services for boys and men of color.
1+ YOEBachelor's degree in public health, psychology, health administration, or related field; 1–2 years in quality assurance, clinical operations, administrative coordination, or behavioral health; EHR and Google Workspace proficiency.
EHR, Google Workspace, Google Sheets, Google Docs, Google Drive
EyePoint PharmaceuticalsNASDAQ: EYPT: Clinical-stage developing sustained-delivery treatments for retinal diseases.
10+ YOEBachelor's or advanced scientific degree, 10+ years in pharmaceutical or biotech industry, 8+ years of GCP QA experience, ICH and regulatory expertise, and extensive clinical auditing experience.
Quality Management System (QMS), FDA, ICH, GCP, Bioresearch Monitoring (BIMO)
Revolution MedicinesNASDAQ: RVMD: Developing precision oncology therapies for RAS-addicted cancers
10+ YOEBachelor’s in scientific or technical field; 10+ years in GCP quality; 8+ years audit/inspection readiness; deep knowledge of ICH GCP and FDA requirements; strong communication; ability to manage multiple priorities.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, Microsoft Visio
ComplexCare Solutions: Provides health assessments and clinical engagement for health plans.
5+ YOERequires a BSN, five years of clinical nursing experience, exceptional clinical and analytical skills, strong organization, and computer proficiency; healthcare quality improvement experience preferred.