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 variations in sampling and testing procedures and assess impacts to data quality and integrity across data sources.

• Assess compliance of documentation and data controls with FDA regulations, guidance, and standard operating procedures

• Evaluate completeness, and consistency and gaps in supporting documentation associated with testing activities

• Identify deviation, inconsistencies from established processes and risks impacting regulatory decisions;

• Provide prioritized, actionable recommendations for corrective and preventive actions (CAPA)

• Support alignment of database practices with regulatory expectations and audit standards

• Prepare a comprehensive final audit report detailing observations, risk areas, and root causes

• Present findings and recommendations to stakeholders across regulatory, scientific, and program leadership teams

• Support implementation planning for process improvements and data governance enhancements

What You Will Need:

• Bachelor’s Degree in Chemistry, Pharmaceutical Sciences, Regulatory Science, Data Science, or related discipline

• Minimum five (5) years of relevant experience in regulatory data analysis, quality assurance, or FDA-regulated environments

• Demonstrated ability to define problems and analyze complex systems within regulatory or scientific domains

• Experience developing analysis plans, evaluating data quality, and supporting regulatory decision-making processes

• Experience coordinating and managing analytical evaluations, audits, or compliance reviews

• Strong knowledge of FDA regulations, data integrity principles (e.g., ALCOA+), and laboratory documentation standards

• Ability to assess system specifications and recommend improvements for implementation

• Excellent written and verbal communication skills, including status reports, technical reports and audit documentation

• Strong critical thinking and problem-solving capabilities in complex regulatory environments

• Hybrid role requiring the ability to work onsite at the client location in Silver Spring, MD

What Would Be Nice To Have:

• Advanced degree (Master’s or PhD) in a relevant scientific or regulatory discipline

• Experience supporting regulatory quality surveillance initiatives, data systems and data management practices.

• Familiarity with drug quality sampling, laboratory testing workflows, and analytical validation processes.

• Experience conducting internal audits or supporting regulatory inspections (e.g., FDA, ISO, GLP).

• Knowledge of database systems used for laboratory data management (e.g., LIMS), scientific instruments and laboratory equipment.

• Experience with data governance, quality frameworks, and process improvement methodologies.

• Experience translating audit findings into operational and system-level improvements

The annual salary range for this position is $85,000.00-$141,000.00. Compensation decisions depend on a wide range of factors, including but not limited to skill sets, experience and training, security clearances, licensure and certifications, and other business and organizational needs.

What We Offer:

Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.

Benefits include:

• Medical, Rx, Dental & Vision Insurance

• Personal and Family Sick Time & Company Paid Holidays

• Parental Leave

• 401(k) Re