Regulatory Compliance Auditor, AI Model Evaluation

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $25 - $50 / hour

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

🔎 Auditor

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Volga Partners

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2020

🤖 Artificial Intelligence

🤝 B2B

🏢 Enterprise

Artificial Intelligence • B2B • Enterprise

Volga Partners is a technology services firm that specializes in Artificial Intelligence and Machine Learning solutions, data annotation and labeling, and development of customer service platforms powered by generative AI. The company also provides IT and software development services across web, app, full-stack, cybersecurity advisory, and e-commerce support, supported by a large multilingual crowd workforce and remote on-demand resources. Volga Partners focuses on partnering with enterprise clients to deliver scalable, cost-effective AI tooling, content moderation, linguistic services, and managed software projects.

📋 Description

• 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 • Analyze 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 • Provide expert feedback, explain findings, identify improvements, and recommend technically accurate corrections • Apply project-specific evaluation criteria, scoring guidelines, and quality standards • Complete independent evaluations using designated online platforms within established project timelines

🎯 Requirements

• Minimum of 4 years of professional experience in Regulatory Compliance, Quality Auditing, GMP Auditing, Supplier Quality, Quality Assurance, or related pharmaceutical functions • Bachelor's degree or higher in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, Engineering, Life Sciences, Regulatory Affairs, or a related discipline • Experience conducting or participating in GMP audits, supplier audits, compliance inspections, or quality system assessments • Strong knowledge of FDA regulations, GMP requirements, and relevant ICH guidelines • Experience evaluating quality systems, compliance programs, and corrective action plans • Familiarity with audit planning, execution, reporting, and CAPA verification activities • Experience reviewing quality, manufacturing, laboratory, or regulatory documentation • Ability to critically evaluate technical and compliance-related information • Strong analytical, research, and problem-solving skills • Excellent written English communication skills • Ability to work independently and follow detailed review instructions • Comfortable working within a task-based freelance engagement model • Lead Auditor certification or equivalent auditing credentials (preferred) • PharmD, MS, MBA, PhD, or other advanced scientific credentials (preferred) • Experience conducting supplier, contract manufacturer, or third-party audits (preferred) • Experience supporting FDA, EMA, MHRA, Health Canada, or international regulatory inspections (preferred) • Experience leading compliance remediation and CAPA effectiveness programs (preferred) • Knowledge of GMP, GDP, GLP, and GCP requirements (preferred) • Experience performing risk-based auditing and compliance gap assessments (preferred) • Experience evaluating Quality Management Systems (QMS) (preferred) • Experience collaborating with Manufacturing, Quality Assurance, Regulatory Affairs, Validation, and Technical Operations teams (preferred) • Experience with technical writing, audit reporting, or compliance documentation review (preferred) • Familiarity with AI evaluation, data annotation, or quality review activities (preferred) • Experience with AI model evaluation, large language models (LLMs), research, or structured quality assessments is beneficial but not required

🏖️ Benefits

• Remote work arrangement • Flexible, project-based assignments • Opportunity to contribute to advanced AI technologies • Supplemental-income freelance work • Experience contributing to AI evaluation initiatives

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