Regulatory Compliance Auditor Subject Matter Expert -AI Model Evaluation

Volga Partners

8d • $25 - $50 • Remote

About The Position

Volga Partners is seeking experienced pharmaceutical or biotechnology Regulatory Compliance Auditors to evaluate AI-generated pharmaceutical content. This is not a traditional auditing role: the work does not involve conducting supplier audits, preparing organizations for inspections, or managing compliance programs. Instead, subject matter experts assess the accuracy, completeness, consistency, technical reasoning, and regulatory compliance of AI-generated content related to pharmaceutical auditing, quality, manufacturing, compliance, supplier oversight, and inspection readiness. Evaluators identify inaccuracies, unsupported claims, missing context, and flawed reasoning, then provide structured feedback grounded in regulatory requirements, audit principles, and pharmaceutical industry practices.

Assignments are completed independently through designated online platforms, using project-specific criteria, scoring guidelines, and quality standards. The role is remote and project-based, with variable, intermittent work assigned as projects become available; hours and future assignments are not guaranteed. Project schedules, workloads, dates, and specific assignment details will be communicated as confirmed. Qualified candidates may be asked to complete screening questions and evaluation exercises before project selection. The role is intended as supplemental freelance work. AI experience is beneficial but not required.

Compensation is project-based and hourly, with the detailed compensation listing stating $25–$50 USD per hour for Regulatory Compliance Auditor SMEs. Rates may vary according to specialization, experience, qualifications, location, and assignment requirements. The posting also gives a general compensation range of $20–$50 USD per hour.

Requirements

• At least 4 years of professional experience in Regulatory Compliance, Quality Auditing, GMP Auditing, Supplier Quality, Quality Assurance, or a related pharmaceutical function.
• 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.
• Comfort working within a task-based freelance engagement model.

Nice To Haves

• Lead Auditor certification or equivalent auditing credentials.
• PharmD, MS, MBA, PhD, or other advanced scientific credentials.
• Experience conducting supplier, contract manufacturer, or third-party audits.
• Experience supporting FDA, EMA, MHRA, Health Canada, or international regulatory inspections.
• Experience leading compliance remediation and CAPA effectiveness programs.
• Knowledge of GMP, GDP, GLP, and GCP requirements.
• Experience performing risk-based auditing and compliance gap assessments.
• Experience evaluating Quality Management Systems (QMS).
• Experience collaborating with Manufacturing, Quality Assurance, Regulatory Affairs, Validation, and Technical Operations teams.
• Experience with technical writing, audit reporting, or compliance documentation review.
• Familiarity with AI evaluation, data annotation, or quality review activities.
• Experience with AI model evaluation, large language models (LLMs), research, or structured quality assessments.

Responsibilities

• Evaluate AI-generated pharmaceutical content for scientific, technical, and regulatory accuracy, completeness, consistency, and compliance with industry standards.
• Review content concerning 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 relevant FDA requirements, GMP regulations, ICH guidelines, and accepted pharmaceutical industry practices.
• Explain evaluation findings, identify improvement opportunities, and recommend technically accurate corrections.
• Apply project-specific evaluation criteria, scoring guidelines, and quality standards to support AI quality improvement.
• Complete independent evaluations through designated online platforms accurately and within established project timelines.

Benefits

• Remote work arrangement.
• Flexible participation based on project needs and availability.
• Opportunity to contribute to AI evaluation initiatives and gain experience with pharmaceutical technology.

What This Job Offers

• Career Level: Mid Level