Senior Project Quality Assurance Lead

🔥 1 hour ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $65.5k - $130.5k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.

📋 Description

• Collaborate with project team members to ensure compliance with study protocols and regulations. • Acts as GCP Subject Matter Expert (SME) providing GCP consultancy to project teams for assigned projects. • Manages and facilitates investigation and root cause analysis for Quality Issues (QIs) including development of Corrective and Preventive Action (CAPA) Plans for assigned projects. • Participates in risk management activities. • Proactive identification of risks to ensure mitigations and controls are in place. • Performs quality assurance review and trending activities for assigned projects. • Provides Clinical Investigator Site inspection and audit support as required. • Provides GCP consultancy and reviews QMD deviations for project teams. • Collaborate with Therapeutic Area Quality Leads within the QMO team and support with managing the QA-to-QA relationship with Sponsor QA counterparts and quality metrics. • Assist with Sponsor audits and regulatory inspections as assigned.

🎯 Requirements

• Bachelor’s degree or equivalent with concentration in biological, physical, health, pharmacy or other related science • 5+ years of relevant GCP experience or 3+ years of relevant GCP with a M.S. or equivalent in a scientific or allied health field • Excellent working knowledge of Quality Management Systems, ICH Guidelines, FDA Code of Federal regulations, European Directives and Regulations, and UK Statutory Instruments relevant to GCP • Excellent understanding of drug development processes • Experience in supporting Regulatory Inspections is preferred • GxP (e.g., GLP, GMP, GPVP, GPP) knowledge in addition to advanced GCP knowledge preferred • Strong influencing and negotiation skills. • Domestic and international travel may be required (not exceeding 15%).

🏖️ Benefits

• Competitive benefits package depending on location • Health insurance • Paid time off