Role Description
At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, and supporting our customers’ medical related inquiries.
The QMS AI Quality & Compliance Specialist is a Quality role responsible for supporting the implementation and operation of Thermo Fisher Scientific’s AI Compliance Program within GxP-regulated environments.
• Support the implementation and maintenance of the enterprise AI Compliance Management System under direction of the Senior Director, AI Compliance.
• Apply established Quality standards, policies, and procedures to AI systems used in GxP-regulated activities.
• Serve as a Quality point of contact for AI-related compliance questions at the project and system level.
Qualifications
• Bachelor’s degree required; preferred fields include Computer Science, Data Science, Artificial Intelligence, Quality, Regulatory Affairs, or a related discipline.
• Minimum 2+ years of experience in Quality, Compliance, Regulatory, or regulated technology roles within pharmaceutical, biotech, or life sciences environments is required.
• Working knowledge of GxP regulations and data integrity principles is required.
• Experience supporting computerized system validation or assurance activities is required.
• Familiarity with AI and machine-learning concepts and their application in regulated environments is required.
• Experience with Quality Management Systems and compliance documentation is required.
• Exposure to AI-enabled systems in clinical, manufacturing, quality, or post-market settings is required.
• Familiarity with data analytics tools or AI platforms (e.g., Python, R, cloud-based analytics) from a Quality oversight perspective is required.
• Professional certification in Quality, Compliance, or Regulatory Affairs is preferred.
• Knowledge of required frameworks such as GAMP 5, ISO 42001, NIST RMF, CRF Part 11 as well as ICH Guidance and emerging AI regulations is preferred.
• Experience supporting audits or regulatory inspections is preferred.
Requirements
• Strong analytical and problem-solving skills with attention to detail.
• Ability to translate technical concepts into clear Quality and compliance guidance.
• Effective written and verbal communication skills.
• Ability to manage multiple priorities in a regulated, fast-paced environment.
• Collaborative mindset with the ability to work independently when required.
Benefits
• Fully remote in the US.
• Relocation assistance is NOT provided.
• Must be legally authorized to work in the US without sponsorship.
• Must be able to pass a comprehensive background check, which includes a drug screening.
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