Remote QA Lead – GxP, CAPA & QMS Excellence

Fortrea; United States; Remote; USD 70,000 - 125,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k)

Paid time off

Bonus where applicable

Job summary

Fortrea is seeking a Quality Assurance Lead to partner with operations, guiding quality issue management, CAPA activities, and data-driven improvements. This remote role serves the US market, ensuring alignment with GxP, GCP, and QMS requirements.

Ideal candidates bring 5+ years in regulated environments, strong CAPA oversight, and the ability to communicate issue summaries to clients. Remote work within the United States is offered along with comprehensive benefits.

Qualifications

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

Responsibilities

• Serve as a quality partner to operational teams by guiding quality issue management and CAPA opportunities.
• Monitor progression of quality issues and escalate risks impacting compliance or client commitments.
• Collaborate to develop, implement, and monitor CAPAs for sustainable issue resolution.
• Maintain knowledge of quality systems, processes, and regulatory requirements to support issue management.
• Analyze quality metrics to identify systemic concerns and drive continuous improvement.

Skills

Quality Assurance

CAPA process

QMS

GxP knowledge

GCP knowledge

Client communication

Education

Bachelor's in Life Sciences

Job description

Fortrea is seeking a Quality Assurance Lead to partner with operations, guiding quality issue management, CAPA activities, and data-driven improvements. This remote role serves the US market, ensuring alignment with GxP, GCP, and QMS requirements.

Ideal candidates bring 5+ years in regulated environments, strong CAPA oversight, and the ability to communicate issue summaries to clients. Remote work within the United States is offered along with comprehensive benefits.