QA Regulatory Data SME

About the role

The 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.

Responsibilities

• 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
• Absess 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

• 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
• 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

Qualifications

• 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

Skills

• Ability to obtain public trust

Benefits

• Annual salary range: $85,000.00 - $141,000.00
• Comprehensive, total rewards package that includes competitive compensation and a flexible benefits package
• 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.)

Pay

• $85,000.00 - $141,000.00

Schedule

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