Ww Vp Quality Management, Apm

BD

Irvine, CA, USA
15+ years quality management experience
Fda/competent authority regulated environment
Medical device industry expertise
The Worldwide Vice President is responsible for shaping the strategic quality agenda and ensuring regulatory compliance throughout the product lifecycle for Advance Patient Monitoring

Job Summary

  • The Worldwide Vice President is responsible for shaping the strategic quality agenda and ensuring regulatory compliance throughout the product lifecycle for Advance Patient Monitoring.
  • This role serves as the designated Management Representative, partnering with business leaders to align quality strategies with corporate priorities and accelerate innovation.
  • Candidates must demonstrate a track record in people management and comprehensive expertise in interpreting worldwide regulatory standards applicable to the medical device industry.

Matching Summary

The Worldwide Vice President is responsible for shaping the strategic quality agenda and ensuring regulatory compliance throughout the product lifecycle for Advance Patient Monitoring.

Skills & Requirements

Must-have

  • 15+ years quality management experience
  • FDA/Competent Authority regulated environment
  • Medical device industry expertise
  • ISO QMSR GMP GLP GCP knowledge
  • Multi-cultural team management
  • CAPA and risk reduction initiatives
  • Management Review Process leadership

Nice-to-have

  • MBA preferred
  • Pharmaceutical GMP experience
  • Lean Six Sigma methodology
  • Innovation acceleration focus
  • Global mindset and collaboration
  • Talent development and succession planning

Key Requirements

  • Minimum 15 years experience in quality management
  • 5-7 years senior compliance management experience
  • BS degree required; advanced technical degree and MBA preferred
  • Experience managing multi-cultural teams globally
  • Expertise in FDA and global Pharmaceutical GMP regulations

Work Rights

Not specified

Tailored Resume

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