Sr. Manager, QMS Governance & Continuous Improvement
- Advanced Degree plus 6 years of experience, or bachelor's degree plus 8 years of experience in pharmaceutical, medical device, or regulated life sciences industry
- Preferred Fields of Study: Science, Engineering, Chemistry, or related technical field
- Professional certifications desired (ASQ, Lean Six Sigma, etc.)
- 5+ years of quality management/leadership experience
- Expert knowledge of global quality standards (ISO 13485, ISO 9001, FDA 21 CFR 820, EU MDR/IVDR)
- Strong understanding of quality management systems and GMP requirements
- Demonstrated experience leading quality investigations, CAPA, and change control processes
- Experience implementing continuous improvement initiatives
- Experience with quality tools including FMEA, Risk Analysis, and Root Cause Analysis
- Excellent project management and cross-functional leadership abilities
- Strong data analysis and problem-solving capabilities
- Excellent written and verbal communication skills
- Ability to build collaborative relationships at all levels
- Experience hosting regulatory inspections and customer audits
- Proficiency with quality management software systems
- Ability to travel up to 25%
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