QA Regulatory Data SME

Guidehouse

QA Regulatory Data SME ensuring accurate regulatory data analysis and compliance for pharmaceutical products. Conducting audits and presenting findings to enhance regulatory decision-making processes.

Posted 6/30/2026full-timeRemote • Maryland • 🇺🇸 United StatesMid-LevelSenior💰 $85,000 - $141,000 per yearWebsite

About the role

Key responsibilities & impact

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

Requirements

What you’ll 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.

Benefits

Comp & perks

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.)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Data Quality EvaluationAnalytical Evaluation ManagementCompliance Review CoordinationProblem Definition and AnalysisAudit Documentation Preparation

Soft Skills

Excellent Communication SkillsStrong Problem-Solving Capabilities