Quality Assurance Manager

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🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🔧 QA Engineer (Quality Assurance)

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Clario

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1973

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 Private Equity Round on 2019-10

Healthcare • Consulting • Logistics

Clario is a company specializing in accelerating clinical trials from initiation to implementation through advanced technologies and services. Since 2018, Clario has revolutionized endpoint analyses in clinical trials by integrating over 30 artificial intelligence-enabled solutions across more than 600 active trials, enhancing data quality and patient privacy while expediting data collection processes. Clario provides a comprehensive clinical trial management platform, offering solutions such as eCOA, cardiac safety, medical imaging, precision motion, and respiratory services in various therapeutic areas including oncology, cardiology, and neurology. Known for its global reach, Clario supports clinical trials in over 100 countries with a strong focus on decentralized and hybrid trial models. The company's commitment to patient safety and innovation is reflected in their over 26,000 trials and involvement in numerous new drug approvals.

📋 Description

• Serve as the primary Quality Assurance liaison for the assigned business unit and provide ongoing QA support • Define and execute quality strategies with Operational and Strategic Quality Management teams • Drive quality improvement initiatives and support business unit quality objectives • Monitor and evaluate quality performance and identify continuous improvement opportunities • Support business development through RFIs, RFPs, quality agreements, and client quality documentation • Act as lead QA contact for strategic clients and support additional clients • Develop and maintain quality policies, procedures, guidance documents, and training materials • Define and maintain site-specific regulatory requirements, quality records, business continuity plans, and compliance controls • Deliver quality-related training and promote quality objectives • Collaborate with project, product, and platform teams to embed privacy, security, and regulatory requirements • Report quality performance, audit outcomes, compliance metrics, vendor audit metrics, and training metrics • Support internal and external inspections, audits, and regulatory interactions • Manage system assessments and categorization activities for new products and initiatives • Provide QA support for platform maintenance, enhancements, documentation management, and long-term records retention

🎯 Requirements

• Bachelor’s degree required • 7 to 10 years of relevant experience in quality assurance, quality management, or a related field within a regulated environment • Extensive knowledge of global GxP regulations and standards, including Good Clinical Practice (GCP), ICH E6, FDA regulations, and regional compliance requirements • Strong understanding of clinical trial technologies, software solutions, and regulated product development environments • Experience interpreting quality data, audit findings, investigations, and Corrective and Preventive Action (CAPA) activities • Knowledge of privacy and security regulations, including GDPR, HIPAA, and related compliance requirements • Ability to work effectively within cross-functional teams while maintaining ownership and accountability for deliverables • Strong business acumen and strategic thinking capabilities • Excellent organizational, interpersonal, verbal, and written communication skills • Ability to manage multiple priorities and deliver against established timelines and milestones • Experience supporting regulatory inspections, audits, supplier oversight, and quality compliance activities in a global environment

🏖️ Benefits

• Quality-focused work supporting clinical research and improved patient outcomes • Opportunity to advance clinical science and build innovative technology • Work with global teams • Work contributing to life-changing therapies reaching patients faster