Associate Director, Clinical Risk Management

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

Company

Johnson & Johnson develops healthcare and MedTech solutions, including medicines and technologies designed to prevent, treat, and cure complex diseases.

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.
• Lead risk monitoring reviews, maintain Clinical Quality Plans, and communicate risk updates through quality working groups and governance forums.
• Provide guidance on significant quality issues, investigations, CAPA plans, effectiveness checks, and escalation to senior R&D management.
• Drive inspection readiness, including inspection narratives, site preparation, document availability, mock inspections, and post-inspection support.
• Develop quality processes, tools, and systems while training and coaching colleagues and new employees.

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 system.
• Strong GCP quality and/or clinical trials experience, including clinical trial risk management fundamentals and work with ICH guidelines.
• Experience with health authority inspections, including FDA, EMA, or other inspectorates.
• Excellent interpersonal, oral, and written communication skills, with the ability to work across culturally diverse and global teams.
• Proficiency in spoken and written English is required. Microsoft Office proficiency is also required.

Nice to have

• Knowledge of GMP, GLP, or GPvP.
• Project planning and management experience.
• Experience managing escalations and advising on CAPA support.
• Experience with Tableau, Spotfire, or similar data analytics and visualization tools.
• Experience with data science, digital health, real-world evidence, or real-world disease data.

Culture & Benefits

• Inclusive work environment focused on individual dignity, diversity, and collaboration.
• Annual bonus or sales commission opportunities depending on role, pay grade, and location.
• Vacation, parental leave of at least 12 weeks, bereavement leave, caregiver leave, and volunteer leave.
• Well-being reimbursement and financial, physical, and mental health programs.
• Insurance plans and service anniversary and recognition awards, subject to applicable plans and location.