Functional Quality Specialist II

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

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

• Take ownership of assigned aspects of quality reviews on projects • Compile metrics and identify quality trends • Assist with periodic client quality reviews and ad-hoc client quality findings • Prepare initial drafts of Corrective and Preventive Actions • Review samples of cases and safety reports for global regulatory submissions and labeling/regulatory documents • Support functional quality operations across the adverse events process • Manage and review expedited adverse events, product quality complaints, and medical information, submitting them to clients and regulatory agencies within required timelines • Own assigned CAPAs and ensure actions are closed with documentary evidence • Contribute to process reviews, process improvements, and process standards • Help design and track training schedules and materials • Initiate discussions on quality errors, identify process improvements, and share best practices • Assist in coordinating client and external audits • Draft sections of Quality Management Plans • Support clients during regulatory inspections at client sites • Promote consistent, efficient, and quality processes in line with timelines, deliverables, and standard operating procedures • Respond to and review medical information queries, product quality complaints, and general queries • Review recorded information received through telephone, email, fax, and other channels • Execute drug safety data management processes, including call intake review, dialogue documentation review, and case follow-up • Guide safety associates in managing voice calls as required • Track information and metrics, perform ongoing quality control, conduct training, and reconcile data from multiple sources • Analyze data and suggest or drive strategies for process improvement and excellence • Perform other duties as assigned

🎯 Requirements

• Bachelor's, Master's, or PhD degree in Medicine, Alternative Medicine, Medical Science, Pharmaceutical Science, Nursing, Life Sciences, or a related area; relevant equivalent experience may substitute for education • Three years of overall work experience in the pharmaceutical, biotechnology, or CRO industry • At least one year of experience in peer review or quality review • Knowledge of regulatory requirements, including GPV and applicable EU and FDA guidelines • In-depth understanding of case processing and assessment • Knowledge of Quality Assurance • Awareness of lean methodology concepts • Technical proficiency with Microsoft Office suite of applications • Experience in pharmacovigilance or safety writing • Experience generating quality metrics with trend analysis, authoring, and coordinating Corrective and Preventive Action Reports preferred • Experience assessing case/safety report quality from medical, scientific, and documentation perspectives preferred • Ability to travel 10% of the time, including overnight stays as necessary

🏖️ Benefits

• Remote work option • Travel availability/overnight stays as necessary, up to 10% of the time • Equal employment opportunity and accommodations support