Sr. Manager, Quality
About The Position
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. 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. This is a fully onsite position based in Middletown, VA. Relocation assistance is NOT provided.
Requirements
- Advanced degree with 6+ years of experience, OR Bachelor’s degree with 8+ years of experience.
- 5+ years of quality management/leadership experience.
- 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.
- Experience hosting regulatory inspections and customer audits.
- 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.
- 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%.
- Must be legally authorized to work in the United States without sponsorship.
- Must be able to pass a comprehensive background check, which includes a drug screening.
Nice To Haves
- Science, Engineering, Chemistry, or related technical field.
- Professional certifications desired (ASQ, Lean Six Sigma, etc.).
Responsibilities
- Guide strategic quality initiatives and support a culture of continuous improvement.
- Oversee quality management systems and ensure regulatory compliance.
- Enhance customer experience through excellent quality standards.
- Develop and implement quality strategies.
- Manage quality assurance and quality control teams.
- Build strong partnerships with operations, R&D, commercial teams, and customers.
- Guide process improvements through Practical Process Improvement (PPI) methodologies and risk-based approaches.
- Maintain inspection readiness and manage customer relationships.
- Ensure compliance with global regulatory requirements.
- Support quality initiatives that deliver consistent product excellence while meeting business objectives.
- Develop quality professionals, lead investigations, and implement data-driven solutions that enhance our quality systems and customer satisfaction.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
