Manager, Clinical Risk Management

Location: Hybrid role based at a J&J office in Allschwil/Basel, Switzerland, or other listed offices in Spring House, Titusville, Raritan, United States, and Beerse, Belgium. Up to 10% travel is required, primarily domestic with some international travel.

Company

Johnson & Johnson develops healthcare solutions and innovative medicines focused on preventing, treating, and curing 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.
• Participate in trial and program activities, advise clinical teams on risk mitigation, and lead regular risk reviews with Risk Owners.
• Maintain Clinical Quality Plans and drive quality risk monitoring and mitigation reviews.
• Communicate risk updates through Quality Working Groups and Governance Forums, escalate systemic risks and significant quality issues, and support quality investigations.
• Advise on CAPA plans and effectiveness checks in collaboration with R&D Quality partners.
• Drive inspection readiness, including inspection narratives, site preparation, document availability, mock inspections, and post-inspection support.

Requirements

• Bachelor’s degree in a scientific, medical, or related discipline.
• At least 8 years of experience in the healthcare, pharmaceutical, contract research, or healthcare/hospital industry.
• Strong GCP quality and/or clinical trials experience.
• Excellent interpersonal, oral, and written communication skills, with the ability to work across culturally diverse and cross-functional teams.
• Proficiency in Microsoft Office Applications.
• Proficiency in spoken and written English is required.

Nice to have

• Experience with clinical trial risk management fundamentals and ICH guidelines.
• Knowledge of GMP, GLP, and/or GPvP.
• Health authority inspection experience with FDA, EMA, or other inspectorates.
• Project planning and management, escalation management, and CAPA support experience.
• Experience with data analytics or visualization tools such as Tableau or Spotfire, plus experience in Data Science or Digital Health.

Culture & Benefits

• Inclusive work environment that respects individual dignity, diversity, and merit.
• Opportunity to contribute to healthcare innovation and the development of future treatments.
• Cross-functional collaboration across international R&D and Quality organizations.
• Hybrid work arrangement with limited domestic and international travel.