Job Summary:
Fortrea, a leading global contract research organization (CRO), is seeking an experienced QA Lead with strong regulatory and GXP experience. This hybrid role involves leading quality issue progression, CAPA support, and QMS compliance across regulatory and clinical research operations. The ideal candidate will bring at least 8 years of experience in a regulated environment with hands-on knowledge of quality systems and processes.
Key Responsibilities:
Drive progression of quality issues in the Quality Management System (QMS)
Monitor timeliness and resolution of quality issue cases in QMS
Assist internal teams in development and execution of Corrective and Preventive Actions (CAPAs)
Maintain strong knowledge of QMS, CAPA, and regulatory quality systems
Collaborate with QA Lead Manager for client notifications and updates
Support data pulling, trend analysis, and quality issue tracking
Perform additional QA-related tasks as assigned
Required Skills & Qualifications:
Bachelor’s degree in Life Sciences preferred (or equivalent life sciences experience)
Minimum 8 years’ experience in a regulatory/GXP environment
Solid understanding of QMS, CAPA, and compliance frameworks
Experience with GCPs/GXPs and quality communication to internal teams and clients
Excellent teamwork and detail-oriented problem-solving skills
Effective communicator capable of summarizing complex quality issues
Perks & Benefits:
Competitive compensation and career advancement in a global CRO
Hybrid work arrangement with flexibility based on line manager request
Access to global projects and cross-functional teams
Work culture defined by Fortrea FOUR: Forward Together, Own It, Uphold Integrity, Respect People
Global exposure across 100+ countries and 20+ therapeutic areas
Company Description:
Fortrea is a global leader in clinical research and technology solutions, serving pharmaceutical, biotechnology, and medical device clients across 100+ countries. With deep scientific expertise and commitment to innovation, Fortrea supports breakthrough therapies from concept to market, transforming drug development worldwide.
Work Mode:
Hybrid (Office-based as per line manager’s request)
Call-to-Action:
Ready to lead quality initiatives at a global CRO? Apply now to join Fortrea as a QA Lead and make a meaningful impact on regulatory compliance and patient safety.
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