Filtration Sr. Quality Manager - Columbia, MO

Thermo Fisher ScientificColumbia, MO
6dOnsite

About The Position

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. 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.

Requirements

  • Advanced Degree with a minimum of 5 years of experience OR Bachelor’s Degree with a minimum of 8 years of 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
  • 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
  • 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
  • Ability to travel up to 25% as required

Nice To Haves

  • Preferred fields of study: Science, Engineering, Chemistry, or related technical discipline
  • Professional certifications preferred (ASQ, Lean Six Sigma, or equivalent)

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

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What This Job Offers

Job Type

Full-time

Career Level

Mid Level

Number of Employees

5,001-10,000 employees

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