Job Description
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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