QA Lead Manager

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🕒 March 25

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• Overseeing Quality Issue Management, ensuring GCP compliance, and providing expert QA support across clinical development teams • Collaborating with business functions to conduct thorough investigations and ensure appropriate CAPAs are identified, developed, implemented effectively • Support development of CAPA plans arising from internal audits, sponsor audits, and regulatory inspections • Maintain up-to-date knowledge of GCP regulations and relevant global/local regulatory expectations • Provide QA consultation and compliance guidance to study teams and cross-functional partners • Lead or support inspection readiness activities, including training, process walkthroughs, documentation reviews, and risk-based preparation • Provide inspection management support during regulatory inspections • Facilitate regular meetings with internal teams and sponsors to discuss quality issues, trends, risks, and continuous-improvement opportunities

🎯 Requirements

• A minimum of a bachelor’s degree in Life Sciences preferred (or equivalent Life Science experience) • 5 years in regulatory environment (experience in GXP roles) • Strong understanding of QMS and CAPA processes • Ability to manage client responsibilities • Report and communicates key quality information to Sr. Managers and QA • Able to work effectively within a team environment • Knowledge of GCPs/GxPs

🏖️ Benefits

• Flexibility in working outside office may be needed to work with global team and clients • Occasional travel required