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DESCRIPTION

As a Senior Manager of Quality at Thermo Fisher Scientific, you will guide strategic quality initiatives and support a culture of continuous improvement across our organization. You'll oversee quality management systems, ensure regulatory compliance, and enhance customer experience through excellent quality standards. Working closely with cross-functional teams, you'll develop and implement quality strategies that support our mission of enabling customers to make the world healthier, cleaner, and safer. In this role, you'll manage quality assurance and quality control teams while building strong partnerships with operations, R D, commercial teams, and customers. You'll guide process improvements through Practical Process Improvement (PPI) methodologies and risk-based approaches. Your leadership will be essential in maintaining inspection readiness, managing customer relationships, and ensuring compliance with global regulatory requirements. As a member of the site leadership team, you'll support quality initiatives that deliver consistent product excellence while meeting business objectives. You'll develop quality professionals, lead investigations, and implement data-driven solutions that enhance our quality systems and customer satisfaction.

REQUIREMENTS

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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Find & Apply For Clinical Quality Manager Jobs in Oakwood Village, Ohio

Sr. Manager, Quality