Job Title:
QA Lead Manager – GCP (On-Site) | Daytona Beach, FL
Job Summary:
Fortrea, a leading global Contract Research Organization (CRO), is seeking an experienced QA Lead Manager – GCP to join its Daytona Beach, FL facility. This full-time, on-site position plays a critical role in ensuring regulatory and GCP compliance for early-phase clinical trials. Ideal for candidates with strong expertise in Quality Management Systems (QMS), CAPA processes, and client audit hosting, this role offers an opportunity to impact drug development and safety at a global scale.
Key Responsibilities:
Manage Quality Issues (QIs) and Corrective and Preventive Actions (CAPAs) to resolution.
Provide regular quality activity reports to senior QA management.
Oversee CAPA and QI completion in Quality Management System (QMS).
Assist internal and external teams with investigations and CAPA creation.
Maintain up-to-date knowledge of GCP and global regulatory requirements.
Support senior QA leadership with data tracking, trending, and client metrics reporting.
Host external audits and inspections, including regulatory and client visits.
Ensure full compliance with Regulatory Compliance (RC) and Quality Assurance (QA) responsibilities.
Perform other duties as assigned.
Required Skills & Qualifications:
Bachelor’s degree in Life Sciences preferred (or equivalent experience).
Minimum 5 years’ experience in a regulatory/GXP environment.
Strong understanding of Quality Management Systems (QMS) and CAPA processes.
Ability to manage client relationships and responsibilities effectively.
Proficient in communicating key quality information to senior management.
Excellent teamwork and communication skills, especially during client meetings.
Comprehensive knowledge of GCPs/GXPs.
Willingness to work overtime, weekends, and travel as required.
Perks & Benefits:
Competitive salary (Not specified in the description).
Comprehensive health insurance (medical, dental, vision).
Life insurance, disability coverage.
401(k) retirement savings plan.
Paid time off and holiday benefits.
Professional growth opportunities within a global CRO.
Employee recognition programs and wellness resources.
Company Description:
Fortrea is a globally recognized Contract Research Organization (CRO) delivering advanced clinical development and technology solutions for pharmaceutical, biotechnology, and medical device industries across 20+ therapeutic areas. Operating in nearly 100 countries, Fortrea drives innovation and efficiency in global drug and device development.
Work Mode:
On-Site – Daytona Beach, Florida
Call to Action:
Ready to lead quality assurance for groundbreaking clinical research? Apply today to become Fortrea’s QA Lead Manager – GCP in Daytona Beach, FL, and play a vital role in global healthcare advancements.
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