Thermo Fisher Scientific · 17 hours ago
Site Quality Manager
Charlotte, NC
Full-time
Onsite
Senior Level
5+ years expThermo Fisher Scientific is a company that enables its customers to make the world healthier, cleaner, and safer. They are seeking a Site Quality Manager to oversee the Quality Management System and ensure compliance with regulatory standards while leading a culture of continuous improvement.
Research
Responsibilities
Develop, implement, and maintain the site's Quality Management System (QMS) aligned with applicable regulatory standards (e.g., ISO9001, GMP, ISO12485)
Lead a culture of continuous improvement, promoting proactive identification and resolution of quality risks
Participate on the site leadership team in planning for the site, incorporating quality initiatives into broader operational goals
Maintain compliance with all applicable regulatory and customer requirements and internal quality standards
Responsible for internal and external audits, including ISO, customer, and other external certifying bodies including implementation of Corrective and Preventive Actions (CAPA) for findings and deviations
Lead and mentor the Quality team to provide the best possible service through effective communication, scientific leadership, and problem solving
Navigate a sophisticated functional and technical matrix, collaborate across functions, troubleshoot problems, interpret data and resolve next steps based on risk-based approach
Track and report key performance indicators to assess quality system efficiency
Ensure equipment qualifications, process validations, and calibration activities are properly completed and documented
Qualification
Required
Bachelor's degree or equivalent experience in a scientific or technical field required
5+ years in Quality Assurance experience in the pharmaceutical, bioprocessing, food and beverage industries, or other regulated industry
Prior direct and matrix people leader experience
Strong working knowledge of Good Manufacturing Practices (GMP), ISO9001, ISO9001, Good Documentation Practices (GDP), and CAPA systems
Strategic problem solver with a practical approach to complex quality challenges
Excellent communication and presentation skills, including use of Microsoft Office tools
Strong organizational and prioritization capabilities
Proficiency in risk management tools such as FMEA, Root Cause Analysis (RCA) and statistical process control (SPC)
Company
Thermo Fisher Scientific
The world leader in serving science To serve science, Thermo Fisher Scientific needs to stay ahead of it, we need to anticipate customer needs.
10001+ employees
H1B Sponsorship
Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (272)
2024 (224)
2023 (233)
2022 (342)
2021 (315)
2020 (227)
Funding
Current Stage
Late StageLeadership Team
Heather Stewart
HR Business Partner - Global Enterprise Services
Laura Green
Associate Human Resources Business Partner
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