Quality Assurance Manager – Clinical

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $100k - $136k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🔧 QA Engineer (Quality Assurance)

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InClin, Inc

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1998

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

InClin, Inc. is a full-service Contract Research Organization (CRO) based in San Mateo, California, and Sydney, Australia. The company specializes in partnering with biotech and pharmaceutical companies to support clinical trials from Phase 1 through Phase 4. InClin provides a range of services including clinical operations, biometrics, medical writing, quality assurance, and strategic consulting, aiming to develop innovative therapies that improve the quality of life for patients worldwide.

📋 Description

• Report directly to the Director of Quality • Manage compliance with company policies, procedures, GCP regulations, and applicable guidelines • Write, revise, and review SOPs, policies, working practices, investigation reports, and quality metric trend reports • Perform audits and maintain Annual Audit Plans for internal departments, CROs, specialty service providers, and clinical studies • Co-host FDA and regulatory inspections • Manage the company-wide electronic Quality Management System (eQMS) for Document Control, Training, Deviations, Complaints, and CAPAs • Oversee Computer System Validation (CSV) and Change Control Management • Review non-conformance situations, evaluate root causes and corrective actions, and ensure timely closure • Act as the designated QA Representative on clinical studies for Protocol Deviation Reviews and Risk Management • Develop quality indicators and metrics to monitor system effectiveness • Deliver GCP training sessions for internal and contract personnel • Champion a culture of continuous improvement across the organization

🎯 Requirements

• B.S. or advanced degree in science, nursing, or a related health sciences discipline • 8+ years of experience within the pharmaceutical, biopharmaceutical, or clinical quality arena • Strong working knowledge of FDA regulations and ICH-GCP guidelines • Familiarity with worldwide regulatory guidelines and 21 CFR Part 11 requirements is preferred • Ability to travel an average of 25% or less, primarily for required vendor or site audits • CQA (Certified Quality Auditor) or RQAP-GxP certification is a strong plus • Previous CRO experience is highly desired

🏖️ Benefits

• Corporate benefits • Paid time off (PTO) • Holidays • 401(k) • Health insurance • Vision insurance • Dental insurance • Completely remote workspace • Collaborative environment • Infrastructure to support success • Competitive compensation