QA Regulatory Data SME
Guidehouse
- Silver Spring, Maryland, United States
- Silver Spring, Maryland, United States
À propos
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, 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) Retirement Plan
Group Term Life and Travel Assistance
Voluntary Life and AD&D Insurance
Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts
Transit and Parking Commuter Benefits
Short-Term & Long-Term Disability
Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities
Employee Referral Program
Corporate Sponsored Events & Community Outreach
Care.com annual membership
Employee Assistance Program
Supplemental 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 bonus
About Guidehouse Guidehouse 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.
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Compétences linguistiques
- English
Avis aux utilisateurs
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