QA Regulatory Data SME

Guidehouse; Washington (District of Columbia); Hybrid; USD 85,000 - 141,000; Full time

Benefits offered by this job

Medical, Rx, Dental & Vision Insurance

401(k) Retirement Plan

Parental Leave

Tuition Reimbursement

Learning Opportunities

Job summary

Guidehouse is conducting an internal audit of a pharmaceutical data system to ensure data integrity and regulatory compliance. The role analyzes data quality, validates adherence to FDA standards, and provides actionable CAPA recommendations.

The work supports regulatory decision-making and strengthens data governance across testing activities. The candidate will review records, identify gaps, and prepare a final audit report with findings and risk assessment, presenting them to stakeholders

Qualifications

• Bachelor’s degree in chemistry, pharmaceutical sciences, regulatory science, data science, or related field.
• 5+ years in regulatory data analysis or FDA-regulated environments.
• Experience with FDA regulations, data integrity (ALCOA+), and lab documentation standards.
• Strong written and verbal communication; ability to prepare technical audit reports.
• Hybrid onsite role at client location in Silver Spring, MD.

Responsibilities

• Review database records for completeness, accuracy, and consistency.
• Analyze variations in sampling and testing procedures and assess data quality impact.
• Assess documentation and data controls for FDA regulations and SOPs.
• Evaluate testing documentation for completeness and gaps.
• Identify deviations and risks; provide CAPA recommendations.
• Support alignment of database practices with regulatory expectations.
• Prepare a comprehensive audit report detailing observations and root causes.
• Present findings to regulatory, scientific, and program leadership teams.

Skills

Regulatory data analysis

FDA regulations

ALCOA+ data integrity

Audit documentation

Regulatory compliance

Technical writing

Education

Bachelor's degree in Chemistry/Pharma/Reg Sci/Data Science

Tools

LIMS

Job description

Job Family:Data Science & AnalysisTravel Required:Up to 10%Clearance Required:Ability to Obtain Public TrustOur 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 consistencyAnalyze 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 proceduresEvaluate completeness, and consistency and gaps in supporting documentation associated with testing activitiesIdentify 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 standardsPrepare a comprehensive final audit report detailing observations, risk areas, and root causesPresent findings and recommendations to stakeholders across regulatory, scientific, and program leadership teamsSupport implementation planning for process improvements and data governance enhancementsWhat You Will Need:Bachelor’s Degree in Chemistry, Pharmaceutical Sciences, Regulatory Science, Data Science, or related disciplineMinimum five (5) years of relevant experience in regulatory data analysis, quality assurance, or FDA-regulated environmentsDemonstrated ability to define problems and analyze complex systems within regulatory or scientific domainsExperience developing analysis plans, evaluating data quality, and supporting regulatory decision-making processesExperience coordinating and managing analytical evaluations, audits, or compliance reviewsStrong knowledge of FDA regulations, data integrity principles (e.g., ALCOA+), and laboratory documentation standardsAbility to assess system specifications and recommend improvements for implementationExcellent written and verbal communication skills, including status reports, technical reports and audit documentationStrong critical thinking and problem-solving capabilities in complex regulatory environmentsHybrid role requiring the ability to work onsite at the client location in Silver Spring, MDWhat Would Be Nice To Have:Advanced degree (Master’s or PhD) in a relevant scientific or regulatory disciplineExperience 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 improvementsThe 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 InsurancePersonal and Family Sick Time & Company Paid HolidaysParental Leave401(k) Retirement PlanGroup Term Life and Travel AssistanceVoluntary Life and AD&D InsuranceHealth Savings Account, Health Care & Dependent Care Flexible Spending AccountsTransit and Parking Commuter BenefitsShort-Term & Long-Term DisabilityTuition Reimbursement, Personal Development, Certifications & Learning OpportunitiesEmployee Referral ProgramCorporate Sponsored Events & Community OutreachCare.com annual membershipEmployee Assistance ProgramSupplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.)Position may be eligible for a discretionary variable incentive bonusAbout GuidehouseGuidehouse is an Equal Opportunity Employer–Protected Veterans, Individuals with Disabilities or any other basis protected by law, ordinance, or regulation.Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco.If you have visited our website for information about employment opportunities, or to apply for a position, and you require an accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at [e-mail]. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.All communication regarding recruitment for a Guidehouse position will be sent from Guidehouse email domains including @guidehouse.com or [e-mail]. Correspondence received by an applicant from any other domain should be considered unauthorized and will not be honored by Guidehouse. Note that Guidehouse will never charge a fee or require a money transfer at any stage of the recruitment process and does not collect fees from educational institutions for participation in a recruitment event. Never provide your banking information to a third party purporting to need that information to proceed in the hiring process.If any person or organization demands money related to a job opportunity with Guidehouse, please report the matter to Guidehouse’s Ethics Hotline. If you want to check the validity of correspondence you have received, please contact [e-mail]. Guidehouse is not responsible for losses incurred (monetary or otherwise) from an applicant’s dealings with unauthorized third parties.Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse and Guidehouse will not be obligated to pay a placement fee.