QMS AI Quality & Compliance Specialist
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: North Carolina • United States
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About the role
- 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
- Provides day-to-day Quality oversight, guidance, and execution support to ensure AI systems are developed, validated, and maintained in compliance with GxP, data integrity, and regulatory expectations
- Works closely with the QMS CDT, QTS and CSV teams as well as Digital, Data Science, IT, and business teams to enable compliant AI adoption while maintaining Quality independence
- Contributes to governance, risk assessments, validation activities, documentation, training, and monitoring of AI systems used in regulated processes
Requirements
- 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
- 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
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
GxP regulationsdata integrity principlescomputerized system validationQuality Management SystemsAI conceptsmachine learningdata analytics toolsPythonRcloud-based analytics
Soft Skills
analytical skillsproblem-solving skillsattention to detailcommunication skillscollaborative mindsetability to manage multiple prioritiesindependenceguidanceoversighttraining
Certifications
Quality certificationCompliance certificationRegulatory Affairs certification