Manager, Clinical Risk Management

Role: Manager, Cross Therapeutic Area Clinical Risk Management within Johnson & Johnson's R&D Quality CRM team, focused on overseeing quality risk processes in clinical trials across multiple regions. Responsibilities: identify, assess, and mitigate risks affecting data integrity, patient safety, and trial compliance; lead risk reviews, develop risk mitigation strategies, and maintain Clinical Quality Plans; support inspection readiness activities, including mock inspections and post-inspection follow-up; provide guidance on quality investigations, CAPA development, and escalation of significant issues; collaborate across global teams and ensure regulatory compliance per ICH, GxP, and relevant standards. Requirements: bachelor’s degree in a scientific or medical discipline; 8+ years in healthcare or pharma industries with proven GCP quality/trial experience; strong communication skills; proficiency in Microsoft Office; experience with risk management fundamentals and working in regulated environments. Preferred: familiarity with ICH guidelines, GMP, GLP, PV practices; inspection experience (FDA, EMA); project management skills; data analytics proficiency; knowledge of digital health and real-world evidence. HighValue: clinical trial risk management, GCP expertise, inspection readiness, international regulatory compliance, cross-functional collaboration, and experience in global pharma or CRO settings. Work setup: primarily on-site with up to 10% travel, mainly domestic and some international.