Manager, Quality Clinical Risk Management

About the role

Johnson & Johnson is looking for a Manager, Quality Clinical Risk Management to join its R&D Quality CRM team. The role is an independent clinical quality-risk leadership position that turns risk signals into proactive mitigation, escalation, inspection and submission readiness, and quality decision support across trials and programs. It combines hands-on risk ownership with significant cross-functional influence, with minimal direction from the RDQ Director. The posting is open to several countries (US, UK, Belgium, Spain, Switzerland) and may appear under different requisition numbers.

Key responsibilities

• Risk management: take part in all study activities, identify and assess key risks in the clinical protocol and set-up, advise the clinical team on mitigation, review risk areas regularly with Risk Owners and maintain CQP risk monitoring information
• Issue consultation, escalation and compliance assessment: interpret quality issues consistently, guide significant quality issues and escalate them to senior management, evaluate serious breaches and advise on CAPA plans and effectiveness checks
• Submission support: lead the cross-functional trial team in pre-submission quality portfolio reviews and coach others
• Inspection readiness: drive inspection preparation with trial teams, coordinate mock inspections, support sponsor-monitor and third-party inspections and supervise others
• Consultancy: give independent advice on research quality and compliance to business partners
• Licensing and acquisition: support quality integration of acquired assets, quality agreements and asset divestment
• Other: take part in working groups, make decisions for compounds and studies with limited supervision, and train and coach peers and new employees

Required profile

• Bachelor's degree or equivalent in a scientific, medical or related discipline
• Minimum 8 years of experience in the healthcare industry (pharmaceutical industry, CRO and/or healthcare/hospital system)
• Proven GCP quality and/or clinical trials experience
• Ability to work in cross-functional teams and in culturally diverse environments
• Willingness to travel up to 10%, mainly domestically with some international travel

Required skills

• Proficiency in Microsoft Office
• Excellent spoken and written English
• Preferred: knowledge of GMP, GLP and/or GPvP, and experience in a Quality function