QA Specialist – Regulatory Compliance (Hybrid) at Fortrea
Job Summary:
Fortrea, a global leader in clinical development, is seeking a highly experienced QA Specialist to join their Regulatory and Compliance team. This hybrid role involves overseeing quality issues, ensuring GxP compliance, leading local quality initiatives, and supporting cross-functional operational teams. The ideal candidate will bring deep experience in GXP auditing and regulatory environments, playing a key role in enhancing QA strategy and regulatory adherence within a dynamic, global CRO.
Key Responsibilities:
Track and manage the progression of quality issues.
Develop and deliver quality training to operational teams.
Provide consultation and guidance on compliance matters.
Support quality improvement projects across multiple sites.
Collaborate with operations and QA teams to resolve quality issues.
Lead local quality initiatives to boost compliance and efficiency.
Ensure adherence to RC and QA responsibilities as per documentation.
Fulfill other quality-related duties as assigned.
Required Skills & Qualifications:
Bachelor’s degree in Life Sciences (or equivalent experience).
Minimum 6 years’ experience in GxP regulatory roles.
Proven experience as a GXP auditor.
Strategic mindset with ability to influence QA strategy.
Effective communication skills across diverse teams.
In-depth understanding of quality systems, standards, and regulations.
Cross-functional knowledge of multiple operational areas.
Preferred Qualifications:
Fortrea may consider relevant work experience in lieu of formal education.
Perks & Benefits:
Hybrid work flexibility (as requested by line manager).
Opportunity to lead high-impact quality initiatives.
Dynamic and collaborative work culture.
Exposure to global regulatory standards and multi-site projects.
Career growth in a leading global CRO.
Company Description:
Fortrea is a global contract research organization (CRO) dedicated to transforming drug and device development. With operations in over 100 countries, Fortrea supports pharmaceutical, biotechnology, and medical device clients through its innovative clinical and regulatory solutions. The company fosters a culture of scientific rigor, integrity, and global collaboration, aiming to accelerate the delivery of life-changing therapies to patients worldwide.
Work Mode:
Hybrid – Office-based with flexibility as determined by the line manager.
Call to Action:
Are you an experienced QA professional ready to make a global impact? Apply now to join Fortrea’s mission-driven team and contribute to shaping the future of drug development.
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