Thermo Fisher Scientific · 1 day ago
Senior Quality Management Specialist
Texas, United States
Full-time
Onsite
Mid, Senior Level
0+ years expThermo Fisher Scientific is a global team that values passion, innovation, and scientific excellence. The Senior Quality Management Specialist provides regional Quality Management support, leads complex quality investigations, and drives operational quality improvements while mentoring junior team members.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
Responsibilities
Perform and lead quality investigations of moderate to high complexity, selecting appropriate methodologies based on risk and scope and ensuring high-quality RCA and CAPA inputs
Support more complex investigations under direction of management, contributing documentation review, evidence gathering and subject matter insight
Provide regional quality consultation to operational teams on SOPs, QMS requirements, regulatory expectations, process adherence and data integrity issues
Identify quality trends and contributes proposals for corrective and preventative actions; partners with QM leadership on continuous improvement initiatives
Support audit and inspection readiness through documentation review, file checks, preparation activities and response coordination
Deliver and support training and capability-building on QMS processes, SOP requirements, systems and quality expectations
Provide mentorship, guidance and, where assigned, supervision to junior Quality Management Specialists
Represent the Quality Management function in cross-functional discussions and working groups within the assigned region
Ensure supported areas maintain operational compliance, discipline and inspection readiness
Qualification
Required
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 5 years)
Strong understanding of GCP, regulatory requirements, enterprise QMS expectations and operational processes
Strong skills in quality investigations, RCA and CAPA development
Ability to interpret complex information and provide clear, actionable quality guidance
Excellent communication, consultancy and stakeholder engagement skills
Strong analytical and problem-solving capabilities with close attention to detail
Ability to organise workload, meet deadlines and adapt to changing priorities
Proficiency with documentation systems, quality tools and MS Office applications
Coaching and mentoring capability for junior staff members
Company
Thermo Fisher Scientific
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
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
Public CompanyTotal Funding
$15.97BKey Investors
National Grid
2025-11-24Post Ipo Debt· $2.42B
2025-09-30Post Ipo Debt· $2.5B
2023-08-07Post Ipo Debt· $2.95B
Leadership Team
Stephen Williamson
Senior Vice President and Chief Financial Officer
Daniella Cramp
Senior Vice President and President, Bioproduction Group
Recent News
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2025-12-31
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2025-12-19
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