Cross-TA Clinical Risk Lead - Quality & Compliance

6010-Biosense Webster Inc. Legal Entity; Geel; Sur place; EUR 80 000 - 138 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Well-being programs

Résumé du poste

Johnson & Johnson is seeking a Manager, Cross Therapeutic Area Clinical Risk Management to join our R&D Quality CRM team. The role involves coordinating identification, assessment, and mitigation of quality risks across trials/programs, ensuring regulatory compliance and inspection readiness.

The position supports activities from Beerse, Belgium, and other global sites, with up to 10% travel. Strong analytics, CAPA, and regulatory knowledge are essential for success.

Qualifications

• Bachelor’s degree in scientific, medical, or related discipline.
• 8+ years in healthcare/pharma/CRO sectors.
• Strong GCP/clinical trials experience.
• Proven cross-functional collaboration and communication skills.

Responsabilités

• Coordinate risk management activities across trials and programs.
• Lead risk mitigation and CAPA support with stakeholders.
• Maintain Clinical Quality Plans and inspection readiness.
• Provide guidance on quality investigations and SQI escalation.
• Support regulatory inspections and readiness.

Connaissances

GCP Quality

Cross-functional work

Project management

Data analytics

Regulatory knowledge

English proficiency

Formation

Bachelor’s degree in science/medical

Outils

Microsoft Excel

Tableau

Spotfire

Description du poste

Johnson & Johnson is seeking a Manager, Cross Therapeutic Area Clinical Risk Management to join our R&D Quality CRM team. The role involves coordinating identification, assessment, and mitigation of quality risks across trials/programs, ensuring regulatory compliance and inspection readiness.

The position supports activities from Beerse, Belgium, and other global sites, with up to 10% travel. Strong analytics, CAPA, and regulatory knowledge are essential for success.