Quality Assurance Manager

Fundació Privada Món Clínic Barcelona; Barcelona; Presencial; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

A leading organization in Barcelona is seeking a QA Manager responsible for ensuring compliance with GCP standards and overseeing quality management processes. The ideal candidate will have extensive experience in clinical research and QA, leading teams and managing regulatory inspections. This full-time hybrid position offers a competitive salary and benefits.

Servicios

Benefits Club

Formación

• 6+ years in clinical research (drugs or medical devices), 4+ years in Clinical QA.
• 2+ years as the main QA lead (Manager, Director, or equivalent).
• Advanced English and Spanish; Catalan is a plus.

Responsabilidades

• Maintain and oversee the QMS in line with GCP, EMA, FDA, ISO, and GDPR standards.
• Manage deviations, CAPAs, risk assessments, and audits.
• Lead a team of QA Officers and host regulatory inspections.

Conocimientos

Problem-solving

Communication

Teamwork

Educación

Degree in Life or Applied Sciences

Postgraduate training in Clinical Research and/or QA Management

Herramientas

Microsoft 365

Google Workspace

Descripción del empleo

As our QA Manager , you will be ultimately responsible for ensuring BCCC’s Quality Management System (QMS) complies with GCP standards, regulatory requirements, and client expectations. You will lead the design, implementation, and continuous improvement of quality processes—including cloud-based digital tools. Key responsibilities include :

• Maintain and oversee the QMS in line with GCP, EMA, FDA, ISO, and GDPR standards.
• Manage deviations, CAPAs, risk assessments, and both internal and external audits.
• Coordinate computerized systems validation, training programs, and vendor qualification.
• Act as a GCP compliance advisor for both internal teams and clients.
• Lead a team of QA Officers and host regulatory inspections (AEMPS, EMA, FDA).

Requirements :

• 6+ years in clinical research (drugs or medical devices), 4+ years in Clinical QA.
• 2+ years as the main QA lead (Manager, Director, or equivalent).
• Proven experience hosting regulatory inspections.
• Degree in Life or Applied Sciences, with postgraduate training in Clinical Research and / or QA Management.
• Advanced English (spoken & written) and Spanish. Catalan is a plus.
• Proficient in cloud-based tools (Microsoft 365, Google Workspace).

Valuable :

• Strong knowledge of GCP (EMA / AEMPS / FDA), GDPR, and relevant ISO standards.
• Strategic thinking, strong problem-solving and decision-making skills.
• Excellent communication and teamwork abilities.

Working conditions :

• Full time position
• Hybrid (on-site & remote)
• Offices located in the center of Barcelona
• Competitive salary range
• Benefits Club

Quality Assurance Manager • Barcelona, Catalonia, Spain