Manager, Quality Clinical Risk Management

$102k - $177.1k

Johnson & Johnson

Johnson & Johnson seeks a Manager of Quality Clinical Risk Management to lead risk identification, mitigation, and escalation across clinical trials and R&D programs. This role combines hands-on risk ownership with cross-functional influence, supporting regulatory submissions, inspection readiness, and quality compliance decisions.

Responsibilities

Identify and assess clinical protocol risks; advise teams on effective mitigation strategies
Lead regular risk monitoring reviews and coach others on risk assessment and mitigation
Develop and escalate significant quality issues per corporate standards to senior management
Lead cross-functional teams in quality portfolio review content development for regulatory submissions
Drive inspection readiness activities including site preparation, mock inspections, and regulatory support

Requirements

Leadership experience in clinical quality, risk management, or regulatory compliance
Knowledge of clinical trial protocols, quality systems, and risk assessment methodologies
Experience with regulatory submissions and health authority interactions
Strong cross-functional collaboration and stakeholder management skills
Familiarity with inspection readiness, CAPA processes, and quality investigations
Ability to work independently with minimal direction from senior management

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Vacancy posted 4 days ago

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