Job Description
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
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 single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
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%
Numbers & Facts
| Location | Oakwood Village, OH |
| Industry | All |
| Company Size | 10,000 employees or more |
| Website | https://corporate.thermofisher.com/en/home.html |
About Company
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of nearly $11 billion, we have approximately 37,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through two premier brands, Thermo Scientific and Fisher Scientific, which offer a unique combination of continuous technology development and the most convenient purchasing options. Our products and services help accelerate the pace of scientific discovery, and solve analytical challenges ranging from complex research to routine testing to field applications.
All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.
If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific.
Thermo Fisher Scientific is an Equal Employment Opportunity and Affirmative Action employer.
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