Remote Quality Assurance Lead - CAPA & GxP Expert

FTINC Fortrea Inc.; North Carolina; Remote; USD 70,000 - 125,000; Full time

Benefits offered by this job

Medical benefits

Dental & Vision

401(k) plan

Paid time off

Company bonus

Job summary

Fortrea is seeking a Quality Assurance Lead for a US-based remote role to strengthen quality processes across clinical research operations. You will collaborate with a cross-functional team to address quality issues, drive CAPA activities, and leverage QMS data to support continuous improvement.

Ideal candidates have at least 5 years in regulatory environments with GxP, GCP knowledge, and a life sciences degree.

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.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

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 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 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

Quality issue management

GxP knowledge

Regulatory experience

Education

Bachelor's degree in Life Sciences

Tools

QMS software

Job description

Fortrea is seeking a Quality Assurance Lead for a US-based remote role to strengthen quality processes across clinical research operations. You will collaborate with a cross-functional team to address quality issues, drive CAPA activities, and leverage QMS data to support continuous improvement.

Ideal candidates have at least 5 years in regulatory environments with GxP, GCP knowledge, and a life sciences degree.