Filtration Sr. Quality Manager Columbia, MO
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Job Location:
Columbia, IN - USA
Monthly Salary:
Not Disclosed
Posted on:
5 hours ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety StandardsJob 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 youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every dayenabling 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. Youll 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 Scientifics 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
- Bachelors 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
Required Experience:
Manager
Key Skills
- APQP
- Quality Assurance
- ISO 9001
- Lean Six Sigma
- PPAP
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Control
- Quality Management
- As9100
- Manufacturing
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
