QA Regulatory Data SME

Guidehouse Inc.

Job Overview

Location

US - Remote (Any location)

Job Type

Full-time

Full Job Description

📋 Description

• 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

• 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.

🏖️ 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.).
• Position may be eligible for a discretionary variable incentive bonus.

Skills & Technologies

Spring

Remote

Degree Required

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Guidehouse Inc.

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About Guidehouse Inc.

Guidehouse Inc. is a global consulting and managed services provider formed in 2018 from the public sector practice of PwC. The company advises public and commercial clients on strategy, technology, risk management, and operations, focusing on energy, financial services, health, defense, and cybersecurity. With 18,000 professionals in over 60 offices worldwide, it delivers implementation support, managed services, and digital solutions to federal agencies, utilities, and Fortune 500 organizations. Guidehouse is majority-owned by Veritas Capital and partners with governments and businesses to address complex regulatory, operational, and innovation challenges.

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