Regulatory Compliance Auditor, AI Model Evaluation

This is a fully remote position, open to applicants in United States.

📋 Description

• Assess AI-generated pharmaceutical content for precision, thoroughness, consistency, and adherence to industry standards.

• Examine scientific and regulatory documentation pertaining to quality systems, manufacturing, validation, submissions, development, and compliance efforts.

• Evaluate whether AI-generated conclusions align with scientific principles, regulatory expectations, and industry best practices.

• Detect unsupported assertions, technical inaccuracies, absence of context, and flawed reasoning.

• Validate data against FDA standards, GMP regulations, ICH guidelines, and accepted practices within the pharmaceutical industry.

• Offer expert insights, clarify findings, highlight areas for improvement, and suggest technically accurate amendments.

• Implement project-specific evaluation criteria, scoring metrics, and quality benchmarks.

• Conduct independent evaluations using assigned online tools while adhering to established project deadlines.

⛳️ Requirements

• At least 4 years of professional experience in Regulatory Compliance, Quality Auditing, GMP Auditing, Supplier Quality, Quality Assurance, or similar pharmaceutical roles.

• A Bachelor's degree or higher in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, Engineering, Life Sciences, Regulatory Affairs, or a related field.

• Experience in conducting or participating in GMP audits, supplier audits, compliance inspections, or quality system evaluations.

• Comprehensive knowledge of FDA regulations, GMP standards, and pertinent ICH guidelines.

• Proven experience in assessing quality systems, compliance initiatives, and corrective action strategies.

• Familiarity with audit planning, execution, reporting, and CAPA verification processes.

• Experience in reviewing quality, manufacturing, laboratory, or regulatory documentation.

• Capacity to critically assess technical and compliance-related data.

• Strong analytical, research, and problem-solving capabilities.

• Exceptional written English communication skills.

• Ability to work autonomously and adhere to detailed review guidelines.

• Comfortable operating within a task-oriented freelance engagement model.

• Lead Auditor certification or equivalent auditing qualifications (preferred).

• Advanced scientific credentials such as PharmD, MS, MBA, PhD, or similar (preferred).

• Experience in conducting supplier, contract manufacturer, or third-party audits (preferred).

• Familiarity with supporting FDA, EMA, MHRA, Health Canada, or international regulatory inspections (preferred).

• Experience in leading compliance remediation and CAPA effectiveness initiatives (preferred).

• Knowledge of GMP, GDP, GLP, and GCP requirements (preferred).

• Experience with risk-based auditing and compliance gap evaluations (preferred).

• Experience appraising Quality Management Systems (QMS) (preferred).

• Experience collaborating with Manufacturing, Quality Assurance, Regulatory Affairs, Validation, and Technical Operations teams (preferred).

• Experience in technical writing, audit reporting, or compliance document review (preferred).

• Familiarity with AI evaluation, data annotation, or quality review tasks (preferred).

• Experience with AI model evaluation, large language models (LLMs), research, or structured quality assessments is advantageous but not mandatory.

🏝️ Benefits

• Remote work opportunities.

• Flexible, project-based assignments.

• Chance to contribute to cutting-edge AI technologies.

• Supplemental-income freelance opportunities.

• Experience in AI evaluation initiatives.