Quality Assurance Lead, US Remote Based

Fortrea; North Carolina; Remoto; USD 70.000 - 125.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical benefits

Dental benefits

Vision benefits

401(k) plan

Paid time off

Descrizione del lavoro

Fortrea is seeking a Quality Assurance Lead for a remote role based in the United States. You will partner with operations to manage quality issues, drive CAPA progress, and utilize QMS data to strengthen quality processes across clinical research operations.

The role requires deep knowledge of GxP, QMS, and CAPA, with 5 years of regulatory experience and a Life Sciences degree or equivalent. Collaboration with senior quality leadership and client communications are key aspects of the position.

Competenze

• 5 years of experience in a regulatory environment, including GxP roles.
• Strong understanding of QMS and CAPA processes.
• Knowledge of GCP and GxP requirements.
• Ability to convey key details of quality issues internally.
• Ability to communicate quality issue summaries to clients.

Mansioni

• Serve as a quality partner to operational teams and guide on quality issue management and CAPA.
• Collaborate with stakeholders to progress issues within the QMS.
• Monitor progression of quality issues and escalate risks impacting compliance or client commitments.
• Develop and monitor CAPAs for long-term issue resolution.
• Maintain knowledge of quality systems, processes, and regulatory requirements.
• Support senior leadership in quality issue progression and client communications.
• Analyze metrics and trends to identify systemic quality concerns and improvement opportunities.
• Prepare quality summaries and trend analyses for stakeholders and clients.
• Contribute to process improvements to strengthen compliance and operational effectiveness.
• Perform other duties as assigned.

Conoscenze

GxP regulatory experience

QMS and CAPA

GCP knowledge

Communicating quality issues

Formazione

Bachelor's degree in Life Sciences or equivalent

Descrizione del lavoro

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