Cross-Therapeutic Clinical Risk Manager

6010-Biosense Webster Inc. Legal Entity; Allschwil; Vor Ort; CHF 150.000 - 210.000; Vollzeit

Zusammenfassung

Johnson & Johnson in Basel-Stadt, Switzerland is seeking a Manager, Cross Therapeutic Area Clinical Risk Management to join the R&D Quality CRM team.

You will lead risk assessment across clinical programs, drive CAPA plans, support inspections, and partner with global teams to ensure regulatory compliance and patient safety. This role requires a strong background in GMP/GLP/GPvP, GCP experience, and excellent communication across diverse stakeholders, with travel up to 10%.

Qualifikationen

• Bachelor’s degree in scientific, medical, or related discipline.
• 8+ years in healthcare/pharmaceutical industries with GCP/clinical trials experience.
• Strong quality and risk management knowledge with cross-functional collaboration.

Aufgaben

• Actively participates in study activities, identifying and assessing key risks in protocols.
• Leads risk reviews with Risk Owners to evaluate mitigations and identify new risks.
• Maintains Clinical Quality Plans and drives quality risk monitoring reviews.
• Communicates risk updates to R&D colleagues and governance forums.
• Guides CAPA development and supports inspection readiness activities.
• Advises on regulatory compliance and quality investigations as needed.

Kenntnisse

Quality management

Risk assessment

Project management

Cross-functional collaboration

GCP knowledge

English proficiency

Willingness to travel

Ausbildung

Bachelor’s degree in scientific/medical field

Tools

Tableau

Spotfire

Jobbeschreibung

Johnson & Johnson in Basel-Stadt, Switzerland is seeking a Manager, Cross Therapeutic Area Clinical Risk Management to join the R&D Quality CRM team.

You will lead risk assessment across clinical programs, drive CAPA plans, support inspections, and partner with global teams to ensure regulatory compliance and patient safety. This role requires a strong background in GMP/GLP/GPvP, GCP experience, and excellent communication across diverse stakeholders, with travel up to 10%.