15+ years quality or regulatory assurance experience
Iso 9001 iso 10993 fda 21 cfr part 820 compliance
Global team leadership across filtration qara functions
Cytiva is seeking a Senior Director of Quality Assurance Filtration to lead a global team and manage a comprehensive quality assurance program within the life sciences and biotechnology sectors. The ideal candidate will have extensive experience in quality or regulatory assurance, particularly in medical devices, and will be responsible for driving quality initiatives and ensuring compliance with industry standards
Job Summary
This role partners globally with internal and external stakeholders to manage a world-class Quality Assurance program supporting business growth.
The position requires leading the global team across all Filtration QARA functions while ensuring compliance with FDA, ISO, and MDR regulations.
Candidates will benefit from comprehensive competitive benefit programs including medical/dental/vision insurance, 401(k), and paid time off.
Matching Summary
Match Score: 85
Cytiva is seeking a Senior Director of Quality Assurance Filtration to lead a global team and manage a comprehensive quality assurance program within the life sciences and biotechnology sectors. The ideal candidate will have extensive experience in quality or regulatory assurance, particularly in medical devices, and will be responsible for driving quality initiatives and ensuring compliance with industry standards.
Salary
Base: $215,000 - $250,000; Bonus/Equity: Eligible for bonus/incentive pay; Benefits: Comprehensive package including health care and 401(k)
Skills & Requirements
Must-have
15+ years Quality or Regulatory Assurance experience
ISO 9001 ISO 10993 FDA 21 CFR Part 820 compliance
Global team leadership across Filtration QARA functions
Medical device manufacturing process knowledge
Root cause analysis CAPA change control expertise
ISO 13485 MDR MD-SAP regulatory requirements
Nice-to-have
Continuous improvement processes and operational excellence
Danaher Business System (DBS) implementation experience
Supplier quality management capabilities
Financial responsibility for functional areas
People development and performance management skills
Key Requirements
Bachelor's degree required
Minimum 15 years work experience in Quality/Regulatory Assurance
10+ years of people leader experience preferably globally
Comprehensive knowledge of medical device compliance standards