Assoc Director, Clinical Risk Management

Location: Hybrid role based at a Johnson & Johnson office in Allschwil, Switzerland, or one of the listed locations in the United States, Belgium, the United Kingdom, or Spain. Up to 10% travel is required, primarily domestic with some international travel.

Company

Johnson & Johnson develops healthcare solutions and innovative medicines and operates across the healthcare and MedTech sectors.

What you will do

• Coordinate the identification, assessment, monitoring, and mitigation of quality risks affecting clinical trial data integrity, patient safety, well-being, and rights.
• Advise clinical and program teams on risk management for complex trials, compounds, and programs.
• Maintain Clinical Quality Plans and lead quality risk monitoring reviews, risk updates, and governance discussions.
• Support quality investigations, significant quality issue escalation, CAPA plans, and effectiveness checks.
• Drive inspection readiness, including inspection narratives, site preparation, document availability, mock inspections, and post-inspection support.
• Provide guidance on research quality, compliance, international regulations, and clinical risk management processes.

Requirements

• Bachelor’s degree in a scientific, medical, or related discipline.
• At least 8 years of experience in the healthcare industry, pharmaceutical industry, contract research organization, or healthcare/hospital system.
• Strong GCP quality and clinical trials experience, including clinical trial risk management and ICH guidelines.
• Health authority inspection experience, including FDA, EMA, or other inspectorates.
• Strong communication, collaboration, project planning, and escalation-management skills.
• Proficiency in spoken and written English is required.

Nice to have

• Knowledge of GMP, GLP, or GPvP.
• Experience with CAPA support and advisement.
• Experience with Tableau, Spotfire, or related data analytics and visualization tools.
• Experience with data science, digital health, real-world evidence, or real-world disease data.

Culture & Benefits

• Work in a cross-functional, culturally diverse, and globally structured healthcare environment.
• Collaborate with R&D Quality, Regulatory Compliance, clinical teams, and subject matter experts.
• Receive opportunities to provide training and coaching to peers and new employees.
• Work in a hybrid office-based setting with limited domestic and international travel.