Global Clinical Risk & Quality Manager

6010-Biosense Webster Inc. Legal Entity; Madrid; Presencial; EUR 62.000 - 106.000; Jornada completa

Descripción de la vacante

Johnson & Johnson in Madrid seeks an experienced Manager, Cross Therapeutic Area Clinical Risk Management to join the R&D Quality CRM team. The role focuses on identifying risks in clinical protocols, guiding mitigation strategies, and ensuring quality across multiple therapeutic areas.

Responsibilities include leading risk reviews, maintaining quality plans, and supporting CAPA and inspections. Excellent English communication and 8+ years in pharma/clinical quality are essential.

Formación

• Minimum a Bachelor's degree in a scientific/medical field.
• At least 8 years in healthcare/pharma or CRO.
• Proven experience in GMP/GLP/GPvP preferred.
• Strong English communication skills (oral/written).
• Knowledge of ICH guidelines and GMP/GLP.

Responsabilidades

• Identify and assess risks in clinical protocols and mitigate strategies.
• Lead risk reviews with risk owners and QA teams.
• Maintain Clinical Quality Plans in quality repositories.
• Provide CAPA guidance and escalate SQIs.
• Support inspections and post-inspection activities.

Conocimientos

GCP Quality

Clinical risk mgmt

Communication skills

MS Office

ICH guidelines

Data analytics

English proficiency

Travel ready

Educación

Bachelor’s in science

Herramientas

MS Office

Descripción del empleo

Johnson & Johnson in Madrid seeks an experienced Manager, Cross Therapeutic Area Clinical Risk Management to join the R&D Quality CRM team. The role focuses on identifying risks in clinical protocols, guiding mitigation strategies, and ensuring quality across multiple therapeutic areas.

Responsibilities include leading risk reviews, maintaining quality plans, and supporting CAPA and inspections. Excellent English communication and 8+ years in pharma/clinical quality are essential.