Senior QMS AI Quality & Compliance Specialist

Job Description

Support the implementation and upkeep of the enterprise AI Compliance Management System, under the guidance of the Senior Director, AI Compliance. Apply established Quality standards, policies, and procedures to AI systems used in GxP-regulated activities. Act as a primary Quality contact for AI-related compliance inquiries at the project and system level. Offer consistent Quality oversight, guidance, and support to ensure AI systems are developed, validated, and maintained in alignment with GxP, data integrity, and regulatory standards. Collaborate with the QMS CDT, QTS, CSV teams, and Digital, Data Science, IT, and business teams to facilitate compliant AI adoption while ensuring Quality independence. Participate in the governance, risk assessments, validation processes, documentation, training, and monitoring of AI systems used in regulated processes.

Qualifications

1. Bachelor’s degree in Computer Science, Data Science, Artificial Intelligence, Quality, Regulatory Affairs, or a related field. 2. Minimum 4+ years of experience in Quality, Compliance, Regulatory, or regulated technology roles within pharmaceutical, biotech, or life sciences environments. 3. Strong understanding of GxP regulations and data integrity principles. 4. Experience supporting computerized system validation or assurance activities. 5. Familiarity with AI and machine-learning concepts and their application in regulated environments. 6. Experience with Quality Management Systems and compliance documentation. 7. Exposure to AI-enabled systems in clinical, manufacturing, quality, or post-market settings. 8. Familiarity with data analytics tools or AI platforms (e.g., Python, R, cloud-based analytics) from a Quality oversight perspective. 9. Professional certification in Quality, Compliance, or Regulatory Affairs is preferred. 10. Knowledge of frameworks such as GAMP 5, ISO 42001, NIST RMF, CRF Part 11, ICH Guidance, and emerging AI regulations is preferred. 11. Experience supporting audits or regulatory inspections is preferred. 12. Strong analytical and problem-solving skills with attention to detail. 13. Ability to translate technical concepts into clear Quality and compliance guidance. 14. Effective written and verbal communication skills. 15. Ability to manage multiple priorities in a regulated, fast-paced environment. 16. Collaborative mindset with the ability to work independently when required.

Benefits

- Relocation assistance is not available for this position. - Candidates must be authorized to work in the US without the need for sponsorship. - Successful completion of a comprehensive background check, including drug screening, is required.