Thermo Fisher Scientific · 17 hours ago
Filtration Sr. Quality Manager - Columbia, MO
Thermo Fisher Scientific is a global leader in serving science, and they are seeking a Senior Quality Manager to provide strategic quality leadership across manufacturing and operational functions. This role involves leading quality initiatives, overseeing quality management systems, and ensuring compliance with regulatory requirements while fostering a culture of continuous improvement.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
Responsibilities
Lead and manage Quality Assurance and Quality Control teams, providing coaching, development, and performance management
Oversee site quality management systems to ensure compliance with GMP, ISO, FDA, and global regulatory requirements
Develop and implement quality strategies aligned with business objectives and Thermo Fisher Scientific’s Mission
Drive continuous improvement initiatives using Practical Process Improvement (PPI), risk-based methodologies, and data-driven decision-making
Lead complex quality investigations, CAPA, and change control processes
Maintain inspection readiness and serve as a key site representative during regulatory inspections and customer audits
Partner cross-functionally with Operations, R&D, Commercial, and Customer teams to enhance product quality and customer satisfaction
Analyze quality metrics and trends to identify risks, opportunities, and system improvements
Build strong customer relationships by ensuring consistent product quality and responsiveness
Qualification
Required
Advanced Degree with a minimum of 5 years of experience OR Bachelor's Degree with a minimum of 8 years of experience
Preferred fields of study: Science, Engineering, Chemistry, or related technical discipline
Professional certifications preferred (ASQ, Lean Six Sigma, or equivalent)
Experience in pharmaceutical, medical device, or regulated life sciences environments
Minimum of 3 years of people leadership or quality management experience
Demonstrated experience leading quality investigations, CAPA, and change control activities
Proven experience implementing continuous improvement initiatives
Experience hosting and managing regulatory inspections and customer audits
Experience partnering cross-functionally at senior leadership levels
Expert understanding of global quality standards including ISO 13485, ISO 9001, FDA 21 CFR 820, and EU MDR/IVDR
Strong knowledge of GMP requirements and quality management systems
Strong project management and cross-functional leadership skills
Advanced problem-solving, risk assessment, and root cause analysis capabilities
Proficiency with quality management systems and data analysis tools
Excellent written and verbal communication skills
Ability to influence and build collaborative relationships at all organizational levels
Ability to lead teams through change and continuous improvement initiatives
Ability to travel up to 25% as required
Must be legally authorized to work in the United States without sponsorship, now or in the future
Must be able to pass a comprehensive background check, including a drug screening
Company
Thermo Fisher Scientific
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
Funding
Current Stage
Public CompanyTotal Funding
$15.97BKey Investors
National Grid
2025-11-24Post Ipo Debt· $2.42B
2025-09-30Post Ipo Debt· $2.5B
2023-08-07Post Ipo Debt· $2.95B
Leadership Team
Recent News
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2026-01-23
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