QA Regulatory Data SME

**Job Family** **:**

Data Science & Analysis

**Travel Required** **:**

Up to 10%

**Clearance Required** **:**

Ability to Obtain Public Trust

Our federal client conducts product testing, quality evaluations, and risk assessments to support market interventions and ensure pharmaceutical manufacturing quality. The associated data repository serves as a critical system of record underpinning regulatory decision-making for pharmaceutical products.

This role supports an internal audit of drug quality sampling and testing databases to ensure data integrity, regulatory compliance, and methodological consistency. The SME will assess data quality, validate adherence to FDA standards, and provide actionable recommendations to strengthen regulatory decision-making processes.

**What You Will Do:**

+ Perform comprehensive reviews of database records to evaluate completeness, accuracy, and consistency
+ Analyze var...