Quality Director - Cytiva Duncan

Cytiva

Duncan, US
Onsite
7+ years quality assurance experience
5+ years leadership experience
Iso standards and fda regulations knowledge
Cytiva is seeking a Quality Director for their Duncan, US location, responsible for leading Quality Assurance and Quality Control teams while ensuring compliance with regulatory standards in life sciences and biotechnology. The role involves driving continuous improvement, building a high-performing team, and advocating for site-specific needs in a collaborative environment

Job Summary

  • This role leads both the Quality Control and Quality Assurance teams at the Duncan site to ensure compliant execution of the QMS.
  • The position requires a strong background in Life Sciences or Biopharma with deep knowledge of ISO standards, FDA regulations, and cGMPs.
  • Candidates will drive continuous improvement using the Danaher Business System while fostering a safe and empowering team environment.

Matching Summary

Match Score: 85

Cytiva is seeking a Quality Director for their Duncan, US location, responsible for leading Quality Assurance and Quality Control teams while ensuring compliance with regulatory standards in life sciences and biotechnology. The role involves driving continuous improvement, building a high-performing team, and advocating for site-specific needs in a collaborative environment.

Skills & Requirements

Must-have

  • 7+ years Quality Assurance experience
  • 5+ years leadership experience
  • ISO standards and FDA regulations knowledge
  • cGMP and CFR requirements expertise
  • CAPA and risk management skills
  • Lean Manufacturing and Six Sigma proficiency

Nice-to-have

  • Danaher Business System mindset
  • Psychological safety culture building
  • Global best practice initiatives
  • Change management advocacy
  • Data-driven decision making

Key Requirements

  • Bachelor's degree in Science, Business, or Engineering
  • Minimum 7 years QA/Quality Engineering experience
  • Minimum 5 years senior leadership experience
  • Experience in FDA/EPA-regulated environments
  • Ability to travel 10% of the time

Work Rights

Not specified

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