Sr. Manager, Quality

Thermo Fisher Scientific Inc

Senior Manager of Quality at Thermo Fisher Scientific overseeing quality management systems, regulatory compliance, and continuous improvement initiatives. This role involves leading quality teams, developing quality strategies, and ensuring global regulatory standards across pharmaceutical and medical device operations.

Responsibilities

Oversee quality assurance and quality control teams while maintaining inspection readiness
Guide process improvements using Practical Process Improvement methodologies and risk-based approaches
Lead quality investigations, CAPA, and change control processes
Develop quality professionals and support cross-functional partnerships with operations, R&D, and commercial teams
Ensure compliance with global regulatory requirements and support customer audit readiness

Requirements

Advanced degree plus 6 years, or Bachelor's degree plus 8 years in pharmaceutical, medical device, or regulated life sciences
5+ years of quality management and leadership experience
Expert knowledge of ISO 13485, ISO 9001, FDA 21 CFR 820, EU MDR/IVDR standards
Proficiency with quality tools: FMEA, risk analysis, root cause analysis
Strong project management and cross-functional leadership abilities
Professional certifications desired (ASQ, Lean Six Sigma)
Ability to travel up to 25%; proficiency with quality management software systems

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Vacancy posted 17 days ago

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