QMS AI Quality & Compliance Specialist

Role Overview

• 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

Tech Stack

• Cloud
• Python

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