[Hiring] Regulatory Compliance Auditor Subject Matter Expert @Volga Partners

Role Description

Help Shape the Future of AI in Pharmaceutical. What if your expertise in pharmaceutical auditing, regulatory compliance, quality systems, and inspection readiness could help artificial intelligence better understand compliance risks, regulatory expectations, and audit best practices?

As a Regulatory Compliance Auditor Subject Matter Expert (SME), you'll serve as a subject matter evaluator, helping assess the quality, accuracy, completeness, and regulatory compliance of Pharmaceutical AI-generated content.

• 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 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.

Requirements

• 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

• Apply Your Industry Expertise in a New Way.
• Help Improve Scientific Accuracy.
• Work Remotely.
• Explore the Future of Pharmaceutical Technology.
• No AI Background Required.