Guidehouse, a "next-generation consultancy" and a portfolio company of Veritas Capital, provides management, risk consulting, and technology services to help cl
QA Regulatory Data SME
Location
Maryland
Posted
5 days ago
Salary
$85K - $141K / year
Seniority
Senior
Job Description
QA Regulatory Data SME
Guidehouse
• 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
Job Requirements
- 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
- 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.)
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