Quality Assurance Lead, US Remote Based
Fortrea
Summary
Join Fortrea and make an impact on quality across our clinical research operations. With the support of a collaborative team, the Quality Assurance Lead helps progress quality issues, support CAPA activities, and leverage QMS data and trends to help strengthen consistent, effective quality processes.
Job description
Key / Core Responsibilities
- Serve as a quality partner to operational teams by providing guidance on quality issue management, quality risk identification, escalation requirements, and continuous improvement opportunities.
- Partner with internal stakeholders to facilitate the progression and resolution of quality issues within the Quality Management System (QMS).
- Monitor and drive timely progression of quality issues while identifying and escalating risks that may impact compliance, quality, or client commitments.
- Collaborate with functional teams to develop, implement, and monitor Corrective and Preventive Actions (CAPAs) to support sustainable issue resolution.
- Maintain a strong working knowledge of quality systems, processes, and regulatory requirements to support effective quality issue management.
- Partner with Quality Lead Managers and senior quality leadership to support quality issue progression, escalation activities, and client communications as required.
- Analyze quality metrics and trends to identify systemic quality concerns, emerging risks, and opportunities for continuous improvement, supporting risk-based decision making.
- Support preparation of quality summaries, trend analyses, and quality-related communications for internal stakeholders and clients, where applicable.
- Contribute to process improvement initiatives that strengthen compliance, quality oversight, and operational effectiveness.
- Perform other duties as assigned.
Required Qualifications
- 5 years of experience in a regulatory environment, including experience in GxP roles.
- Strong understanding of QMS and the CAPA process.
- Knowledge of GCP and GxP requirements.
- Ability to convey key details of quality issues internally.
- Ability to communicate quality issue summaries to clients, where applicable.
- A bachelor’s degree in Life Sciences preferred, or equivalent Life Science experience.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Requirements
- 5 years of experience in a regulatory environment, including experience in GxP roles.
- Strong understanding of QMS and the CAPA process.
- Knowledge of GCP and GxP requirements.
- Ability to convey key details of quality issues internally.
- Ability to communicate quality issue summaries to clients, where applicable.
- A bachelor’s degree in Life Sciences preferred, or equivalent Life Science experience.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Benefits
- Medical, Dental & Vision
- Life Insurance
- Short Term Disability
- Long Term Disability
- 401(k)
- Paid Time Off
- Flexible Time Off
- Company Bonus
Company overview
Fortrea Holdings Inc. is a leading global contract research organization (CRO) that provides comprehensive clinical development solutions to the pharmaceutical, biotechnology, and medical device industries. Headquartered in Durham, North Carolina with operations in over 90 countries, Fortrea specializes in managing all aspects of clinical trials from Phase I through IV, including clinical pharmacology and post-approval services. The company offers a wide range of services including regulatory affairs, protocol design, operational planning, patient recruitment, project management, data management, biostatistics, pharmacovigilance, and medical writing. With over 30 years of clinical research experience, Fortrea has evolved from its heritage as Covance and Labcorp into a pureplay CRO focused on delivering agile, fit-for-purpose solutions for both emerging and established life sciences companies. The company has conducted more than 5,850 clinical trials involving over 1 million subjects in the past five years, with particular expertise in oncology, central nervous system disorders, rare diseases, and cell and gene therapies.