Quality Assurance Lead, US Remote Based
Join Fortrea and make an impact on quality across our clinical research operations. With the support of a collaborative team, the Quality Assurance Lead helps progress quality issues, support CAPA activities, and leverage QMS data and trends to help strengthen consistent, effective quality processes.
Location: Remote, United States
Key / Core Responsibilities
• 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) to support sustainable issue resolution.
• Maintain a strong working knowledge of quality systems, processes, and regulatory requirements to support effective quality issue management.
• Partner with Quality Lead Managers and senior quality leadership to support quality issue progression, escalation activities, and client communications as required.
• Analyze quality metrics and trends to identify systemic quality concerns, emerging risks, and opportunities for continuous improvement, supporting risk-based decision making.
• Support preparation of quality summaries, trend analyses, and quality-related communications for internal stakeholders and clients, where applicable.
• Contribute to process improvement initiatives that strengthen compliance, quality oversight, and operational effectiveness.
• Perform other duties as assigned.
Required Qualifications
• 5 years of experience in a regulatory environment, including experience in GxP roles (Must have GCP work experience).
• Strong understanding of QMS and the CAPA process.
• Knowledge of GCP and GCP experience a MUST 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.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Fortrea is unable to provide employment sponsorship for this position, now or in the future. Candidates must be authorized to work in the United States without sponsorship.
Work Environment
• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestic and international.
Physical Requirements:
• 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.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Regular and consistent attendance.
• Varied hours may be required.
Pay Range: USD $70,000-$125,000
Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable.
Application Deadline: November 17, 2026
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Learn more about our EEO & Accommodations request here.
Skills Required
- At least 5 years of experience in a regulatory environment, including GxP experience
- Strong understanding of Quality Management Systems and the CAPA process
- Knowledge of GCP and GxP requirements
- Ability to communicate key details of quality issues internally
- Ability to communicate quality issue summaries to clients when applicable
- Bachelor's degree in Life Sciences or equivalent Life Science experience
- Equivalent relevant experience may substitute for educational requirements
- Must be authorized to work in the United States without employment sponsorship
What We Do
Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.
