Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:

Join our team at Thermo Fisher Scientific as a Senior Compliance Specialist, where you will play a key role in advancing the compliant adoption of Artificial Intelligence (AI) across our GxP-regulated environment.  This role will serve as subject matter expert for AI governance, validation, and compliance, helping to establish and evolve the processes, standards, and controls that enable responsible use of AI technologies throughout their lifecycle. 

In this role, you will partner with cross-functional stakeholders to develop, implement, and continuously improve compliance programs that address the unique governance, validation, auditability, and risk management requirements of AI-enabled systems.  You will be a key contributor in integrating AI-specific requirements into our standard operating procedures (SOPs).  In addition, you will develop and execute AI-focused test strategies, mentor team members on AI validation and governance practices, represent the IT organization on enterprise AI governance committees and strategic initiatives, and support regulatory inspections and client audits

The successful candidate will possess a strong understanding of computerized systems validation and GxP compliance, alongside real-world experience in emerging AI regulatory expectations and industry best practices. This includes frameworks and regulations such as FDA 21 CFR Part 11, GxP, ICH GCP, the EU AI Act, NIST AI Risk Management Framework, and other evolving global guidance related to trustworthy and compliant AI.

Additional responsibilities may include providing general validation services for GxP applications, including validation planning, risk assessments, test authoring and execution, documentation, and lifecycle compliance activities. The role may also support broader systems compliance initiatives, business analysis efforts, and other internal or external audit-related activities as needed.

Through these efforts, you will help strengthen Thermo Fisher Scientific's compliance framework while supporting our mission of enabling our customers to make the world healthier, cleaner, and safer.

REQUIREMENTS:

• Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in compliance, quality systems, or information technology
• Preferred Fields of Study: Computer Science, Business Systems, Analytics, Engineering, or Sciences
• Professional certifications in technology, compliance, audits or related fields preferred
• Expertise in the governance, management, and validation of AI-enabled computer systems in a GxP environment.
• Expertise in quality management systems and regulatory standards (GxP, ISO, etc)
• Experience with compliance management software
• Proven ability to develop and implement standard operating procedures (SOPs)
• Strong project management and risk assessment capabilities
• Effective stakeholder management and cross-functional collaboration skills
• Advanced problem-solving and analytical skills
• Strong written and verbal communication abilities
• Demonstrated ability to lead internal/external audits
• Proficiency in Microsoft Office Suite and relevant compliance tools
• Strong attention to detail and ability to maintain accurate records
• Ability to work independently while contributing to team objectives
• Travel may be required