Senior Director Qa - U&fm

Danaher

Duncan, SC, USA
**
Bachelor's degree in quality or regulatory field
10+ years experience in quality or regulatory assurance
Knowledge of iso 9001, iso 13485, fda 21 cfr part 820
** Danaher is seeking a Senior Director for Quality Assurance at Cytiva, focused on driving quality initiatives in life sciences and biotechnology. The role requires extensive experience in Quality and Regulatory Assurance, with strong leadership skills to foster collaboration and meet strategic business objectives. **

Job Summary

  • The Senior Director Q&A leads the Quality function within the Hardware Solutions Business Unit to drive business strategy and long-term growth.
  • This role requires comprehensive knowledge of medical device compliance standards including ISO 13485 and FDA regulations to ensure product quality.
  • Candidates must demonstrate strong global leadership skills with over 10 years of people management experience in a regulated environment.

Matching Summary

Match Score: 75

** Danaher is seeking a Senior Director for Quality Assurance at Cytiva, focused on driving quality initiatives in life sciences and biotechnology. The role requires extensive experience in Quality and Regulatory Assurance, with strong leadership skills to foster collaboration and meet strategic business objectives. **

Skills & Requirements

Must-have

  • Bachelor's degree in Quality or Regulatory field
  • 10+ years experience in Quality or Regulatory Assurance
  • Knowledge of ISO 9001, ISO 13485, FDA 21 CFR Part 820
  • Experience with CAPA, change control, and risk management
  • Global leadership experience managing people

Nice-to-have

  • Previous experience in Operations, R&D, or Engineering
  • Understanding of manufacturing processes and product assembly
  • Ability to travel internationally up to 50% of time
  • Valid driver's license with acceptable record
  • Cleanroom entry capability for production spaces

Key Requirements

  • Minimum 10+ years work experience in Quality/Regulatory
  • Bachelor's degree required
  • Valid driver's license required
  • Ability to enter cleanrooms regularly
  • Willingness to travel up to 50% internationally

Work Rights

Not specified

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