Senior Manager, Clinical Quality Risk (Hybrid)

Regulatory Jobs; Pennsylvania; On-site; USD 102,000 - 177,000; Full time

Job summary

Johnson & Johnson is seeking a Manager, Quality Clinical Risk Management to join the R&D Quality CRM team. This role oversees translating risk signals into proactive mitigation, escalation, and quality decision support across trials and programs.

It combines hands-on risk ownership with cross-functional influence. The position requires extensive experience in clinical quality, CAPA, and regulatory readiness, with up to 10% travel and global collaboration across sites in the US and Europe.

Qualifications

• Proficiency in Microsoft Office Applications
• Proficiency in speaking and writing English
• Excellent interpersonal, oral, and written communication skills
• Proven strong GCP quality and/or clinical trials experience
• Experience collaborating in a cross-functional team environment
• Flexibility to respond to changing business needs
• Demonstrates ability to operate in an environment of culturally diverse styles and business approaches

Responsibilities

• Actively participates all study activities, contributing to identification and assessment of key risks and advising clinical teams on mitigation strategies.
• Leads regular review of risk areas with Risk Owners to evaluate progress of mitigations and identify new risks.
• Maintains Clinical Quality Plans risk monitoring information to facilitate progress reviews.
• Drives quality risk monitoring reviews and coaches others on risk monitoring and mitigation reviews.
• Communicates risk updates to RDQ CRM management through Quality Working Groups and Governance Fora.
• Highlight new potential systemic risk to RDQ CRM management.
• Develops and ensures a consistent interpretation of issues requiring quality investigations.
• Provides guidance for significant quality issues and escalation to senior RDQ management.
• Provides initial serious breach evaluation for issues that may require reporting to Health Authorities.
• Advises on CAPA Plans and Effectiveness Checks with cross-functional partners.
• Pre-submission Quality Portfolio Review and leads Cross-Functional Trial Team in QPR content development.
• Coaches and mentors on QPR for coordination and management of activities.
• Drives inspection readiness activities and coordinates mock inspections with Regulatory Compliance teams.

Skills

MS Office

English proficiency

Interpersonal communication

GCP/clinical trials experience

Cross-functional collaboration

Adaptability

Diversity awareness

Education

BA/BSc or equivalent (Scientific, medical, or related discipline)

Job description

Johnson & Johnson is seeking a Manager, Quality Clinical Risk Management to join the R&D Quality CRM team. This role oversees translating risk signals into proactive mitigation, escalation, and quality decision support across trials and programs.

It combines hands-on risk ownership with cross-functional influence. The position requires extensive experience in clinical quality, CAPA, and regulatory readiness, with up to 10% travel and global collaboration across sites in the US and Europe.