Quality Assurance Lead, US Remote Based

FTINC Fortrea Inc.; North Carolina; Remote; USD 70,000 - 125,000; Full time

Benefits offered by this job

Medical benefits

Dental & Vision

401(k) plan

Paid time off

Company bonus

Job summary

Fortrea is seeking a Quality Assurance Lead for a US-based remote role to strengthen quality processes across clinical research operations. You will collaborate with a cross-functional team to address quality issues, drive CAPA activities, and leverage QMS data to support continuous improvement.

Ideal candidates have at least 5 years in regulatory environments with GxP, GCP knowledge, and a life sciences degree.

Qualifications

• 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.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

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 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 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.

Skills

Quality management

CAPA process

Quality issue management

GxP knowledge

Regulatory experience

Education

Bachelor's degree in Life Sciences

Tools

QMS software

Job description

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.


• 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.


• 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 bebased on a candidate’s skills and prior relevant experience, applicabledegrees/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 2, 2026

Learn more about our EEO & Accommodations request here.

Didn’t find what you were looking for? Join our Global Talent Network to stay connected with Fortrea, drive innovation and contribute to our mission of advancing life‑saving therapies for patients worldwide. Follow us and stay updated about Fortrea on LinkedIn, Facebook, X, Instagram, YouTube and Glassdoor.

At Fortrea, we're all about turning the “impossible” into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job – it's a journey of making the exceptional possible, every day.