Quality Assurance Lead, US Remote Based

Fortrea; Durham (NC); À distance; USD 70 000 - 125 000; Plein temps

Avantages offerts par ce poste

Medical

Dental

Vision

Life Insurance

STD/LTD

401(K)

PTO or Flexible time off

Bonus where applicable

Résumé du poste

Fortrea seeks a Quality Assurance Lead to strengthen quality across clinical research operations in a remote U.S. setting. You will guide quality issue management, capture trends, and leverage QMS data to drive improvements and ensure client commitments are met.

The role requires 5+ years in a regulatory environment with GxP experience, strong QMS/CAPA knowledge, and familiarity with GCP/GxP standards. Collaboration with senior leaders and cross-functional teams is essential.

Qualifications

• :

Responsabilités

• 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.

Connaissances

Quality Management

CAPA process

GxP compliance

GCP knowledge

Regulatory environment

Communication of issues

Formation

Bachelor's degree in Life Sciences

Equivalent Life Science experience

Description du poste

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

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