QA Manager, Clinical Trials (Hybrid — Flexible Hours)

Solutiaghs; Barcelona; Presencial; EUR 55.000 - 85.000; Jornada completa

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

Fixed Contract

Hybrid position – 3 days Office – 2 days Home

Flexible entry hours

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

Analytical skills

Problem-solving

Effective communication

Interpersonal skills

Organizational skills

Educación

Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biology, Chemistry

Certification in quality assurance

Descripción del empleo

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.