Filtration Sr. Quality Manager - Columbia, MO
ThermoFisher Scientific
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
**Job Description**
**Position:** Filtration Sr. Quality Manager
**Location:** Columbia, MO
**Schedule:** Typical M-F Days, some occasional weekend work
**Division / Site Specific Information**
This role is part of the site leadership team at Thermo Fisher Scientific and provides strategic quality leadership across manufacturing and operational functions. The Senior Manager of Quality partners closely with Operations, R&D, Commercial, and Customer teams to ensure consistent product excellence, regulatory compliance, and continuous improvement across the site.
**Discover Impactful Work**
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every day—enabling our customers to make the world healthier, cleaner, and safer.
As the Senior Manager of Quality, you will lead strategic quality initiatives while fostering a culture of continuous improvement and accountability. You’ll oversee quality management systems, drive inspection readiness, and elevate customer experience through strong quality standards. Your leadership will help ensure compliance with global regulatory requirements while supporting innovative solutions that advance science and improve lives.
**A Day in the Life**
+ 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
**Keys to Success**
**Education**
+ 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**
+ 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
**Knowledge**
+ 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
**Skills**
+ 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
**Abilities**
+ 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
**Other**
+ 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
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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