GMP Compliance & Validation Subject Matter Expert -AI Model Evaluation

Volga Partners

8d • $25 - $50 • Remote

About The Position

Volga Partners is seeking experienced pharmaceutical and biotechnology professionals to evaluate AI-generated content related to pharmaceutical GMP compliance, validation, qualification, quality, manufacturing, engineering, and inspection readiness. This is not a traditional validation or compliance role: the contractor will not execute validation protocols, lead qualification activities, manage compliance programs, or support regulatory inspections. Instead, the role applies existing industry expertise to assess the accuracy, completeness, consistency, reasoning, and regulatory compliance of AI-generated pharmaceutical content.

The work involves reviewing scientific and regulatory information, identifying errors, unsupported claims, missing context, and flawed reasoning, and providing clear, structured feedback and technically accurate corrections. Evaluations draw on FDA requirements, GMP regulations, ICH guidelines, validation principles, and accepted pharmaceutical industry practices. Assignments are completed independently through designated online platforms, using project-specific criteria and quality standards.

This is a remote, project-based independent contractor opportunity intended as supplemental income. Work is variable and task-based; assignments may be irregular or intermittent, and hours and future assignments are not guaranteed. Project duration, schedules, workloads, and dates depend on requirements and assignment availability. The primary location is the United States, though professionals elsewhere may be considered if they have substantial U.S. pharmaceutical industry experience. Qualified candidates may need to complete screening questions and evaluation exercises before selection. AI experience is beneficial but not required.

Requirements

• At least 4 years of professional experience in GMP compliance, validation, quality engineering, manufacturing compliance, computer system validation, or a related pharmaceutical function.
• Bachelor's degree or higher in Pharmaceutical Sciences, Pharmacy, Chemistry, Chemical Engineering, Biotechnology, Biomedical Engineering, Life Sciences, Engineering, or a related discipline.
• Experience supporting validation and qualification activities in regulated pharmaceutical or biotechnology environments.
• Experience with process validation, cleaning validation, equipment qualification, facility qualification, or computerized system validation.
• Strong knowledge of FDA regulations, GMP requirements, and relevant ICH guidelines.
• Familiarity with data integrity principles, 21 CFR Part 11 requirements, and risk-based validation approaches.
• Experience reviewing validation documentation, protocols, reports, and compliance records.
• Strong analytical, research, and problem-solving skills.
• Excellent written English communication skills.
• Ability to work independently and follow detailed review instructions.
• Comfort with a task-based freelance engagement model.

Nice To Haves

• PharmD, MS, MBA, PhD, or other advanced scientific credentials.
• Experience leading process validation or cleaning validation programs.
• Expertise in IQ/OQ/PQ protocol development and execution.
• Experience supporting FDA, EMA, MHRA, or other regulatory inspections.
• Knowledge of Annex 11, GAMP 5, and data integrity requirements.
• Experience with Continued Process Verification (CPV) programs.
• Experience performing compliance assessments, gap analyses, and remediation activities.
• Experience collaborating with Manufacturing, Quality Assurance, Engineering, Regulatory Affairs, and Technical Operations teams.
• Experience with technical writing, validation documentation review, or compliance assessments.
• 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 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.
• Reference relevant FDA requirements, GMP regulations, ICH guidelines, and accepted pharmaceutical industry practices to validate information.
• Explain evaluation findings and recommend technically accurate corrections and improvements.
• Apply project-specific evaluation criteria, scoring guidelines, and quality standards to support AI quality improvement.
• Complete independent evaluations on designated online platforms accurately and within established project timelines.

What This Job Offers

• Career Level: Mid Level