Senior Director, Quality Risk Management & Regulatory Intelligence (usa)

Johnson & Johnson Innovative Medicine

Horsham, Pennsylvania, United States of America
$178,000.00 - $307,050.00; not specified; not spec...
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Quality risk management framework
Regulatory intelligence program
Gxp compliance
** Johnson & Johnson is seeking a Senior Director for Quality Risk Management & Regulatory Intelligence, responsible for overseeing risk management and regulatory intelligence functions within the Innovative Medicine division. The role requires extensive experience in quality compliance and leadership, with a focus on strategic decision-making and external industry trend monitoring. **

Job Summary

  • Oversee end-to-end risk management processes, ensuring comprehensive risk assessments, effective mitigation strategies, and continuous monitoring are implemented across the organization.
  • Build and lead a dedicated team that analyzes external industry trends and inspection outcomes to identify focus areas for improvement.
  • Establish, implement, and maintain a quality risk management program in compliance with ICH Q9 and other applicable GxP Risk Management requirements.

Matching Summary

Match Score: 75

** Johnson & Johnson is seeking a Senior Director for Quality Risk Management & Regulatory Intelligence, responsible for overseeing risk management and regulatory intelligence functions within the Innovative Medicine division. The role requires extensive experience in quality compliance and leadership, with a focus on strategic decision-making and external industry trend monitoring. **

Salary

$178,000.00 - $307,050.00; Not specified; Not specified

Skills & Requirements

Must-have

  • Quality Risk Management framework
  • Regulatory Intelligence Program
  • GxP compliance
  • risk-based methodologies
  • strategic decision-making
  • Quality Management System integration

Nice-to-have

  • external influencing with Health Authorities
  • predictive risk monitoring
  • process excellence experience
  • global experience

Key Requirements

  • BS degree required
  • 15+ years of experience
  • 5+ years leadership in quality function
  • 5+ years people leader experience
  • Expert knowledge on US and EMEA Regulations
  • Experience building QRM and Regulatory Intelligence programs

Work Rights

Not specified

Tailored Resume

Cover Letter