QA Lead
Location: Available in 3 locations
Category: Regulatory/Compliance
Job ID: 25660
Company: Fortrea
Company Overview
Fortrea is a leading global contract research organization (CRO) providing clinical development, patient access, and technology solutions across 20+ therapeutic areas. Operating in ~100 countries, Fortrea is transforming drug and device development to improve patient outcomes worldwide.
Role Overview
The QA Lead is responsible for overseeing Quality Management System (QMS) operations, tracking quality issues (QI), and ensuring regulatory compliance across Good Clinical Practices (GCP) and other GxP environments. The role involves CAPA management, quality issue resolution, client communication, and process improvement to maintain Fortrea’s high-quality standards in clinical research.
Key Responsibilities
Quality Management & Compliance
Oversee quality issue tracking and timeliness of cases in QMS.
Work closely with internal teams to resolve quality issues.
Maintain strong knowledge of QMS and CAPA processes.
Support teams in creating and implementing CAPAs.
Assist in quality issue case progression and client notifications.
Process Improvement & Metrics Management
Support QA Lead Manager in pulling metric data, trending, and tracking of QI.
Identify process inefficiencies and propose corrective and preventive actions (CAPAs).
Ensure compliance with GCPs, GxPs, and other regulatory guidelines.
Stakeholder Collaboration & Reporting
Communicate quality issue summaries to internal teams and clients.
Collaborate with cross-functional teams to improve quality processes.
Provide support for audits, inspections, and regulatory compliance assessments.
Assist in client notifications regarding quality issues and regulatory actions.
Required Qualifications & Experience
Education:
Bachelor’s degree in Life Sciences preferred (or equivalent Life Science experience).
Relevant experience may be considered in lieu of educational requirements.
Experience:
8+ years of experience in a regulated environment with GXP roles.
Strong knowledge of QMS, CAPA processes, and regulatory compliance (GCP, GxP, FDA, EMA, ICH guidelines, etc.).
Skills & Competencies:
Strong analytical and problem-solving skills in quality management.
Ability to work effectively within a team environment.
Excellent communication and stakeholder management skills.
Proficiency in tracking and reporting quality metrics.
Experience in regulatory inspections and audit preparation is a plus.
Work Environment & Travel Requirements
Office-based role with long hours in front of a computer.
Travel required based on project needs.
About Fortrea
Fortrea is committed to advancing clinical trials and quality compliance through innovation and collaboration. We foster a diverse and inclusive work environment, empowering professionals to make a global impact.
Equal Opportunity Employer Statement
Fortrea is an Equal Opportunity Employer (EOE/AA) and does not tolerate discrimination based on race, gender, disability, veteran status, or any other legally protected category.
For more details, visit www.fortrea.com.
If you require accommodations during the hiring process, please contact taaccommodationsrequest@fortrea.com.
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