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QA Manager, Clinical Trials (Hybrid — Flexible Hours)
Descripción de la vacante
A leading company in biotech is seeking a QA Manager in Barcelona to oversee their Quality Management System (QMS). This role involves ensuring compliance with FDA and EMA regulations, collaborating with various teams, and managing audits, all while maintaining the integrity of clinical data. The ideal candidate possesses strong experience in QA in the biotech or pharmaceutical industry and will enjoy a hybrid working model with flexible hours.
Servicios
Formación
- Minimum 6 years of experience in clinical quality assurance in biotech, pharmaceutical, or CRO.
- In-depth knowledge of ICH-GCP, EMA and FDA regulations.
- Familiarity with Quality Risk Management (QRM) approach.
Responsabilidades
- Lead and oversee all aspects of the Quality Management System (QMS).
- Develop, implement and maintain a Quality Risk Management (QRM) process.
- Support regulatory inspections and manage CAPA processes.
Conocimientos
Educación
* El índice de referencia salarialse calcula en base a los salarios que ofrecen los líderes de mercado en los correspondientes sectores. Su función es guiar a los miembros Prémium a la hora de evaluar las distintas ofertas disponibles y de negociar el sueldo. El índice de referencia no es el salario indicado directamente por la empresa en particular, que podría ser muy superior o inferior.