Cross-TA Clinical Risk Manager — Quality & Compliance

6084-Janssen Research & Development, LLC Legal Entity; Titusville (NJ); Hybrid; USD 102,000 - 177,000; Full time

Job summary

Johnson & Johnson is seeking a Manager, Cross Therapeutic Area Clinical Risk Management to join our R&D Quality CRM team. The role coordinates risk assessment and mitigation across trials and programs, ensuring data integrity, patient safety, and regulatory compliance.

Based in multiple US sites with domestic travel, the position requires strong GCP experience and CAPA leadership. The role emphasizes collaboration with trial teams, risk owners, and governance bodies to maintain inspection

Qualifications

• Bachelor's degree in a scientific, medical, or related discipline.
• 8+ years in the healthcare/pharmaceutical industry.
• Strong GCP quality and/or clinical trials experience.
• Excellent interpersonal, oral, and written communication for cross-functional collaboration.
• Flexibility to adapt to changing business needs.
• Experience navigating diverse regional/global business structures.
• Proficiency with MS Office applications.
• Experience with ICH guidelines and GMP/GLP/GPvP preferred.
• Experience with inspections by Health Authorities (FDA/EMA) preferred.
• Strong project planning/management and CAPA support skills.
• Experience with data analytics/visualization to drive decisions.

Responsibilities

• Coordinate identification, assessment, and mitigation of quality risks in trials/programs.
• Lead regular risk reviews with Risk Owners and mitigation tracking.
• Maintain Clinical Quality Plans and risk matrices in quality repositories.
• Drive quality risk monitoring and coach teams on risk mitigation.
• Communicate risk updates to RDQ CRM and governance bodies.

Skills

GCP Quality

Clinical Trials

Data Analytics

Communication Skills

Project Management

English Proficiency

Education

Bachelor's degree in scientific/medical field

Tools

Tableau

Spotfire

Job description

Johnson & Johnson is seeking a Manager, Cross Therapeutic Area Clinical Risk Management to join our R&D Quality CRM team. The role coordinates risk assessment and mitigation across trials and programs, ensuring data integrity, patient safety, and regulatory compliance.

Based in multiple US sites with domestic travel, the position requires strong GCP experience and CAPA leadership. The role emphasizes collaboration with trial teams, risk owners, and governance bodies to maintain inspection