Quality Assurance Lead, US Remote Based

NCBioImpact; Durham (NC); Remote; USD 70,000 - 125,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Life insurance

Short/Long-term disability

401(k) plan

Paid time off

Job summary

Fortrea seeks a Quality Assurance Lead to drive issue management, CAPA execution, and trend analysis across clinical quality operations in a remote US-based role. You will partner with operational teams, monitor quality metrics, and support client communications.

The role requires 5+ years in a regulated environment with GxP, solid QMS/CAPA experience, and strong ability to articulate quality issues and risk to internal teams and clients.

Qualifications

• 5+ years in a regulatory environment, including GxP roles.
• Strong understanding of QMS and CAPA processes.
• Knowledge of GCP and GxP requirements.

Responsibilities

• Serve as a quality partner to operational teams by guiding quality issue management, risk identification, escalation, and continuous improvement.
• Partner with internal stakeholders to progress and resolve quality issues within the QMS.
• Monitor progression of quality issues and escalate risks impacting compliance, quality, or client commitments.
• Develop, implement, and monitor CAPAs to support sustainable issue resolution.
• Maintain knowledge of quality systems and regulatory requirements to support issue management.
• Support quality leadership in issue progression, escalation, and client communications.
• Analyze quality metrics and trends to identify systemic concerns and opportunities for improvement.
• Contribute to quality summaries, trend analyses, and communications for stakeholders and clients.

Skills

QMS knowledge

CAPA process

GCP/GxP familiarity

Quality issue communication

Regulatory experience

Education

Bachelor’s degree in Life Sciences

Equivalent experience

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 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 2, 2026

Learn more about our EEO & Accommodations request here.