Job Title:
QA Lead
Company:
Fortrea
🌐 www.fortrea.com
Job Details:
Job ID: 254012
Category: Regulatory / Compliance
Work Location: Available in 3 locations (not specified)
Work Environment: Office-based (Hybrid), as assigned by Line Manager
Travel: May be required
About Fortrea:
Fortrea is a leading global Contract Research Organization (CRO) operating in nearly 100 countries. The company provides clinical development and technology solutions to pharmaceutical, biotechnology, and medical device companies across more than 20 therapeutic areas.
Fortrea is committed to transforming clinical research through innovation, collaboration, and scientific rigor. The Fortrea FOUR values define its culture:
Forward Together
Own It
Uphold Integrity
Respect People
Job Summary:
The QA Lead will support and manage quality issues within the Quality Management System (QMS), ensuring compliance, timely tracking, and coordination of Corrective and Preventive Actions (CAPAs). This role is essential for maintaining high standards of GXP compliance and will require close collaboration with internal teams and leadership.
Key Responsibilities:
📌 Quality Issue Management
Collaborate with internal teams to address and resolve quality issues within the QMS
Track timeliness and status of cases in QMS to ensure workflow compliance
Support teams in the creation and management of CAPAs
📊 QMS & Metrics
Maintain a strong working knowledge of QMS processes and tools
Assist QA Lead Manager in gathering metric data, trending quality issues, and tracking quality indicators (QI)
🤝 Stakeholder Interaction
Communicate and escalate quality issue cases as needed to QA Lead Manager and senior leadership
Prepare and communicate quality issue summaries for client notifications when applicable
🛠️ Additional Responsibilities
Support continuous improvement initiatives across QA operations
Perform all other duties as needed or assigned
Required Qualifications:
🎓 Education:
Bachelor’s degree in Life Sciences (preferred)
Fortrea may consider relevant and equivalent experience in lieu of a formal degree
💼 Experience:
Minimum 8 years of experience in a regulatory environment (with experience in GXP roles)
Proven understanding of:
GCPs/GXPs
QMS operations
CAPA process
Preferred Qualifications:
Strong ability to:
Collaborate across teams
Clearly communicate quality issues internally and externally
Summarize and report client-facing documentation when required
Work Environment:
Hybrid work model – office-based with flexibility, depending on manager’s direction
Travel may be required based on project or audit needs
Equal Opportunity & Accessibility:
Fortrea is an Equal Opportunity Employer and will consider all qualified applicants without discrimination based on:
Race, color, religion
Gender, gender identity, or sexual orientation
National origin, disability, veteran status, or other protected categories
Fortrea provides reasonable accommodations for individuals with disabilities during the hiring process and employment lifecycle.
🔗 Learn more about accommodations here
Why Join Fortrea?
Be part of a mission-driven organization focused on global clinical excellence
Join a workplace where collaboration, compliance, and quality matter
Thrive in a team that values personal growth, innovation, and scientific rigor
Help ensure the safety and efficacy of medical products around the world
How to Apply:
🔗 Apply through the Fortrea Careers Portal
📤 Job ID: 254012
📍 Available in 3 locations
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