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Director, Quality Systems

Cytokinetics · South San Francisco, CA

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QualityFull-time$225k–$263kCompany career page

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Role summary

Cytokinetics seeks a Director of Quality Systems to lead quality management, document control, and GxP training functions. The role provides strategic oversight of quality systems operations, regulatory compliance, and team development within a specialty cardiovascular biopharmaceutical company.

What they're looking for

  • Bachelor's degree in life sciences
  • 12+ years biopharmaceutical industry experience
  • 7+ years leading Quality Systems in regulated life sciences
  • 5+ years progressive people management experience
  • Strong QMS, CAPA, Change Control, and Deviation expertise
  • In-depth knowledge of quality principles and industry standards
  • Veeva Quality Vault experience preferred

What you'll be doing

  • Provide strategic direction for Quality Systems organization and oversee QMS, document control, and GxP training groups
  • Lead, mentor, and develop Quality Systems teams while managing performance and career progression
  • Ensure quality systems comply with FDA, EMA, ICH, and GxP regulations and maintain continuous improvement
  • Oversee document control program and GxP training curricula across the company
  • Establish metrics, dashboards, and lead inspection readiness activities for quality system health

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