Position: QA Lead
Category: Regulatory / Compliance
Job ID: 254012
Locations: Available in 3 locations
About the Role
The QA Lead plays a crucial role in supporting Quality Management System (QMS) activities and ensuring compliance with GxP standards. This role involves tracking quality issues, supporting CAPA creation, and collaborating across teams to maintain Fortrea’s high-quality standards. The QA Lead also assists in data analysis, trend reporting, and quality improvement initiatives under the supervision of QA Lead Managers.
Key Responsibilities
Collaborate with internal teams to progress quality issues within the QMS.
Monitor and ensure timeliness of case closures in QMS.
Support teams in the creation and documentation of Corrective and Preventive Actions (CAPAs).
Maintain a strong working knowledge of the Quality Management System (QMS).
Coordinate with QA Lead Managers and higher leadership for quality case progression and client communications.
Assist QA Lead Manager with metric data collection, trend analysis, and quality issue (QI) tracking.
Perform all other duties as required or assigned.
Qualifications (Minimum Required)
Education: Bachelor’s degree in Life Sciences preferred (or equivalent experience in Life Science domain).
Experience: Minimum 8 years in a regulatory environment with hands-on experience in GxP roles.
Technical Knowledge:
Strong understanding of QMS and CAPA processes.
Knowledge of GCPs/GXPs and their application in quality management.
Skills:
Excellent teamwork and communication abilities.
Strong attention to detail and ability to convey key quality issue summaries to clients.
Data tracking and analytical skills for metric and trend reporting.
Preferred Qualifications
Relevant and equivalent experience may be considered in lieu of formal educational requirements.
Work Environment & Physical Demands
Work Setup: Office-based (Hybrid), as requested by the line manager.
Travel: May be required depending on business needs.
About Fortrea
Fortrea is a leading global Contract Research Organization (CRO) providing clinical development and technology solutions across more than 20 therapeutic areas in over 100 countries. Guided by our core values—Forward Together, Own It, Uphold Integrity, and Respect People—we are committed to transforming drug and device development, ensuring faster delivery of life-changing therapies to patients worldwide.
🌐 Learn more: www.fortrea.com
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