Remote QA Lead: CAPA & QMS Excellence

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

Benefits offered by this job

Medical

Dental

Vision

Life Insurance

STD/LTD

401(K)

PTO or Flexible time off

Bonus where applicable

Job summary

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

• :

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.

Skills

Quality Management

CAPA process

GxP compliance

GCP knowledge

Regulatory environment

Communication of issues

Education

Bachelor's degree in Life Sciences

Equivalent Life Science experience

Job description

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.