Regulatory Compliance Auditor Subject Matter Expert - AI Model Evaluation
V
Volga PartnersPharmaceutical AI
Remote | United States | Project-Based Independent Contractor; Professionals outside the United States may be considered if they possess substantial U.S. pharmaceutical industry experienceContractSenior
Salary25 - 50 USD per hour
Apply NowOpens the employer's application page
Job Details
- Languages
- Excellent written English communication skills
- Experience
- Minimum of 4 years of professional experience in Regulatory Compliance, Quality Auditing, GMP Auditing, Supplier Quality, Quality Assurance, or related pharmaceutical functions
Requirements
- Have a minimum of 4 years of professional experience in Regulatory Compliance, Quality Auditing, GMP Auditing, Supplier Quality, Quality Assurance, or related pharmaceutical functions.
- Hold a bachelor's degree or higher in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, Engineering, Life Sciences, Regulatory Affairs, or a related discipline.
- Have experience conducting or participating in GMP audits, supplier audits, compliance inspections, or quality system assessments.
- Have strong knowledge of FDA regulations, GMP requirements, and relevant ICH guidelines.
- Have experience evaluating quality systems, compliance programs, and corrective action plans.
- Be familiar with audit planning, execution, reporting, and CAPA verification activities.
- Have experience reviewing quality, manufacturing, laboratory, or regulatory documentation.
- Be able to critically evaluate technical and compliance-related information.
- Have strong analytical, research, and problem-solving skills.
- Have excellent written English communication skills and be able to work independently while following detailed review instructions.
- Be comfortable working within a task-based freelance engagement model.
Responsibilities
- Evaluate AI-generated pharmaceutical content for accuracy, completeness, consistency, and compliance with industry standards.
- Review scientific and regulatory information related to quality systems, manufacturing, validation, submissions, development, and compliance activities.
- Assess whether AI-generated conclusions are supported by scientific principles, regulatory expectations, and industry best practices.
- Identify unsupported claims, technical inaccuracies, missing context, and flawed reasoning.
- Validate information against FDA requirements, GMP regulations, ICH guidelines, and accepted pharmaceutical industry practices.
- Explain findings, identify improvement opportunities, and recommend technically accurate corrections.
- Apply project-specific evaluation criteria, scoring guidelines, and quality standards.
- Complete independent evaluations using designated online platforms within project timelines.
View Full Description & ApplyYou'll be redirected to the employer's site
