The World Leader In Serving Science

QMS AI Quality & Compliance Specialist

Artificial IntelligenceArtificial IntelligenceFull TimeRemoteMid LevelTeam 10,001+Since 1956H1B SponsorCompany Site LinkedIn

Location

North Carolina

Posted

29 days ago

Salary

Not specified

Seniority

Mid Level

Bachelor Degree2 yrs expExperience acceptedEnglishCloudPython

Job Description

• 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

Job 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