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

Johnson & Johnson MedTech

Horsham, Pennsylvania, United States of America
Base: $178,000.00 - $307,050.00; bonus/equity: not...
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Quality risk management framework
Regulatory intelligence program
Gxp compliance
** Johnson & Johnson MedTech is seeking a Senior Director for Quality Risk Management & Regulatory Intelligence to oversee risk management processes and regulatory intelligence programs within the Innovative Medicine Quality & Compliance organization. The role demands extensive experience in quality functions and leadership, with a focus on proactive risk management and effective communication with regulatory authorities. **

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.
  • Serve as a key participant in industry forums and conferences to gain insights into emerging trends and developments within the industry.

Matching Summary

Match Score: 75

** Johnson & Johnson MedTech is seeking a Senior Director for Quality Risk Management & Regulatory Intelligence to oversee risk management processes and regulatory intelligence programs within the Innovative Medicine Quality & Compliance organization. The role demands extensive experience in quality functions and leadership, with a focus on proactive risk management and effective communication with regulatory authorities. **

Salary

Base: $178,000.00 - $307,050.00; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • Quality Risk Management framework
  • Regulatory Intelligence Program
  • GxP compliance
  • ICH Q9
  • Health Authority Inspections
  • risk-based methodologies

Nice-to-have

  • strategic decision-making
  • influencing global Health Authorities
  • Systems Thinker
  • Process Excellence

Key Requirements

  • BS degree required
  • 15 years of experience
  • 5 plus years leadership in quality function
  • 5 years people leader experience
  • Comprehensive GxP, GMP, cGMP knowledge
  • Expert US and EMEA Regulations knowledge
  • Experience building QRM and Regulatory Intelligence programs
  • Experience with auditing, investigation, remediation, and inspections

Work Rights

Not specified

Tailored Resume

Cover Letter