[Hiring] Pharmaceutical Quality Assurance Subject Matter Expert @Volga Partners

Role Description

Help Shape the Future of AI in Pharmaceutical. At Volga Partners, we're connecting experienced pharmaceutical quality professionals with opportunities to contribute to the development and evaluation of advanced AI models.

We're seeking Pharmaceutical Quality Assurance professionals who can apply their expertise in quality systems, compliance, investigations, and GMP operations to evaluate AI-generated pharmaceutical content.

This isn't a traditional position. You won't be preparing submissions, managing product registrations, or interacting with health authorities. Instead, you'll:

• Evaluate complex regulatory content
• Identify technical inaccuracies
• Assess regulatory reasoning
• Provide structured feedback that improves AI model performance

Your pharmaceutical expertise is what matters. AI experience is a plus, not a requirement.

Important Note: This is a freelance, task-based role designed for those seeking supplemental income. It’s essential to understand the nature of freelance work—tasks will be assigned as they become available, and work may be irregular or intermittent.

What You'll Do

• Evaluate AI-generated pharmaceutical content: Assess scientific, technical, and regulatory responses for accuracy, completeness, consistency, and compliance with industry standards.
• Review scientific and regulatory information: Examine content related to quality systems, manufacturing, validation, submissions, development, and compliance activities.
• Analyze technical reasoning: Determine whether AI-generated conclusions are supported by relevant scientific principles, regulatory expectations, and industry best practices.
• Identify errors and inconsistencies: Recognize unsupported claims, technical inaccuracies, missing context, and flawed reasoning.
• Validate information: Reference relevant FDA requirements, GMP regulations, ICH guidelines, and accepted pharmaceutical industry practices.
• Provide expert feedback: Clearly explain findings, identify opportunities for improvement, and recommend technically accurate corrections.
• Support AI quality improvement: Apply project-specific evaluation criteria, scoring guidelines, and quality standards.
• Complete independent evaluations: Use designated online platforms to complete assignments accurately and within established project timelines.

Qualifications

• Minimum 4 years of pharmaceutical QA experience
• Bachelor's degree or higher in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, or a related discipline
• Experience with 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
• Comfortable working within a task-based freelance engagement model

Preferred Qualifications

• 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 is beneficial but not required.

Compensation

• Pharmaceutical Quality Assurance Subject Matter Expert (SME): $25-$50 USD/hour
• Compensation may vary based on experience level, area of expertise, and task complexity.

Project Details

• Engagement Type: Project-based independent contractor
• Work Arrangement: Remote
• Primary Location: United States preferred
• Additional Markets: Professionals outside the United States may be considered if they possess substantial U.S. pharmaceutical industry experience
• Schedule: Variable and assignment-based
• Project Type: Pharmaceutical AI content evaluation
• Project Duration: Based on project requirements and assignment availability
• Selection Process: Qualified candidates may be required to complete screening questions and evaluation exercises prior to project selection

Who We're Looking For

We're seeking experienced Regulatory Affairs professionals in the Pharmaceutical world who bring practical industry expertise and are comfortable reviewing technical information, exercising independent judgment, and clearly explaining their conclusions.

Why Join Volga Partners?

• Apply Your Industry Expertise in a New Way: Use the knowledge you've developed throughout your regulatory affairs career to contribute to advanced AI technologies.
• Help Improve Scientific Accuracy: Your evaluations will help strengthen the quality and reliability of AI-generated pharmaceutical and regulatory information.
• Work Remotely: Participate in project-based assignments from an eligible location, with flexibility based on project availability.
• Explore the Future of Pharmaceutical Technology: Gain experience contributing to AI evaluation initiatives while leveraging your existing regulatory expertise.
• No AI Background Required: We're looking for professionals who can identify regulatory risks, evaluate compliance considerations, and communicate expert assessments clearly.