QMS AI Quality & Compliance Specialist- fully remote!

Work Schedule Standard (Mon-Fri) Environmental Conditions Office

Job 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. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us. What will you do in this 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. Interested in learning more about this opportunity? 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. Reporting to the Senior Director, AI Compliance Quality/Compliance, this role 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. This position 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. The role contributes to governance, risk assessments, validation activities, documentation, training, and monitoring of AI systems used in regulated processes. Minimum Qualifications: Education requirements: Bachelor's degree required; preferred fields include Computer Science, Data Science, Artificial Intelligence, Quality, Regulatory Affairs, or a related discipline In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Experience requirements: 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. Knowledge, Skills and Abilities: 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 Location: 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.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Apply today! ;br> Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Accessibility/Disability Access Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

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