Quality Assurance Lead

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $70k - $125k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 0%

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• Serve as a quality partner to operational teams by providing guidance on quality issue management, quality risk identification, escalation requirements, and continuous improvement opportunities • Partner with internal stakeholders to facilitate the progression and resolution of quality issues within the Quality Management System (QMS) • Monitor and drive timely progression of quality issues while identifying and escalating risks that may impact compliance, quality, or client commitments • Collaborate with functional teams to develop, implement, and monitor Corrective and Preventive Actions (CAPAs) • Maintain working knowledge of quality systems, processes, and regulatory requirements to support quality issue management • Partner with Quality Lead Managers and senior quality leadership on quality issue progression, escalation activities, and client communications • Analyze quality metrics and trends to identify systemic quality concerns, emerging risks, and opportunities for continuous improvement • Support preparation of quality summaries, trend analyses, and quality-related communications for internal stakeholders and clients • Contribute to process improvement initiatives strengthening compliance, quality oversight, and operational effectiveness • Perform other duties as assigned • Occasionally drive to site locations and travel domestically and internationally

🎯 Requirements

• 5 years of experience in a regulatory environment, including experience in GxP roles • Strong understanding of QMS and the CAPA process • Knowledge of GCP and GxP requirements • Ability to convey key details of quality issues internally • Ability to communicate quality issue summaries to clients, where applicable • A bachelor’s degree in Life Sciences preferred, or equivalent Life Science experience • Relevant and equivalent experience may be considered in lieu of educational requirements • Candidates must be authorized to work in the United States without sponsorship • Ability to access and use a variety of computer software developed both in-house and off-the-shelf • Regular and consistent attendance • Varied hours may be required • Frequently stationary for 6-8 hours per day • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists • Occasional crouching, stooping, with frequent bending and twisting of upper body and neck • Light to moderate lifting and carrying objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

🏖️ Benefits

• Medical • Dental • Vision • Life insurance • Short-term disability (STD) • Long-term disability (LTD) • 401(K) • Paid time off (PTO) or Flexible time off (FTO) • Company bonus where applicable