Pharmaceutical Quality Assurance Subject Matter Expert - AI Model Evaluation
About The Position
Volga Partners is seeking experienced pharmaceutical quality assurance professionals to evaluate AI-generated pharmaceutical and biotechnology content. The role assesses the accuracy, completeness, consistency, reasoning, and regulatory compliance of content related to quality systems, manufacturing, validation, submissions, development, and compliance activities. Evaluators identify technical inaccuracies, unsupported claims, missing context, and flawed conclusions; validate information against FDA requirements, GMP regulations, ICH guidelines, and accepted industry practices; and provide clear, structured feedback and corrections using project-specific criteria. This is a remote, task-based freelance engagement for supplemental income, not a traditional regulatory affairs position. Assignments are completed independently through designated online platforms and are offered as they become available; schedules and workloads are variable, and hours or future assignments are not guaranteed. Project duration depends on requirements and assignment availability. Qualified candidates may need to complete screening questions and evaluation exercises. AI experience is not required.
Requirements
- At least 4 years of pharmaceutical quality assurance experience.
- Bachelor's degree or higher in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, or a related discipline.
- Experience in GMP-regulated environments.
- Understanding of QMS, CAPA, deviations, and change control systems.
- Strong analytical and technical review skills.
- Ability to critically evaluate technical and regulatory 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
- Quality systems leadership experience.
- Inspection readiness experience.
- Supplier quality management experience.
- ASQ certification or equivalent quality credentials.
- Experience managing post-approval changes and variations.
- Technical writing or document review experience.
- 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 accuracy, completeness, consistency, and compliance with industry standards.
- Review scientific and regulatory information 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 FDA requirements, GMP regulations, ICH guidelines, and accepted pharmaceutical industry practices.
- Explain findings, identify opportunities for improvement, and recommend technically accurate corrections.
- Apply project-specific evaluation criteria, scoring guidelines, and quality standards to support AI quality improvement.
- Complete independent evaluations using designated online platforms, accurately and within established project timelines.
Benefits
- Remote work with flexibility based on project availability.
- Opportunity to contribute pharmaceutical expertise to AI evaluation initiatives.
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What This Job Offers
Career Level
Mid Level
