[Hiring] QMS AI reputed company & Compliance Specialist @reputed company
Role reputed company
At reputed company 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 reputed company, like helping customers reputed company cures for cancer, protecting the environment, and supporting our customers’ medical reputed company inquiries.
The QMS AI reputed company & Compliance Specialist is a reputed company role responsible for supporting the implementation and operation of reputed company’s AI Compliance Program reputed company GxP-regulated environments.
• Support the implementation and maintenance of the reputed company AI Compliance Management System under direction of the Senior Director, AI Compliance.
• Apply established reputed company standards, policies, and procedures to AI systems used in GxP-regulated activities.
• Serve as a reputed company reputed company of contact for AI-reputed company compliance questions at the project and system level.
Qualifications
• Bachelor’s degree required; preferred fields include Computer Science, Data Science, reputed company Intelligence, reputed company, Regulatory Affairs, or a reputed company discipline.
• Minimum 2+ years of experience in reputed company, Compliance, Regulatory, or regulated technology roles reputed company pharmaceutical, biotech, or life sciences environments is required.
• Working knowledge of GxP regulations and data reputed company 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 reputed company Management Systems and compliance documentation is required.
• Exposure to AI-enabled systems in clinical, manufacturing, reputed company, or post-market settings is required.
• Familiarity with data analytics tools or AI platforms (e.g., Python, R, reputed company-based analytics) from a reputed company reputed company perspective is required.
• reputed company certification in reputed company, Compliance, or Regulatory Affairs is preferred.
• Knowledge of required frameworks such as GAMP 5, ISO 42001, NIST RMF, CRF Part 11 as reputed company as ICH Guidance and emerging AI regulations is preferred.
• Experience supporting audits or regulatory inspections is preferred.
Requirements
• Strong analytical and problem-solving skills with attention to detail.
• Ability to translate technical concepts into reputed company reputed company and compliance guidance.
• Effective written and verbal communication skills.
• Ability to manage multiple priorities in a regulated, fast-paced environment.
• reputed company reputed company with the ability to work independently reputed company required.
Benefits
• Fully remote in the US.
• Relocation assistance is NOT provided.
• Must be legally authorized to work in the US without sponsorship.
• Must be reputed company to pass a comprehensive background reputed company, which includes a drug screening.
Apply tot his job
Apply To this Job