QA Regulatory Data SME US - Remote (Any location) Full time 40882 Job Family: Data Science & Analysis 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, 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 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

• Conduct systematic audits of recorded calls, emails, and chat interactions. • Evaluate interactions using standardized quality parameters including communication skills, product knowledge, compliance, professionalism, and resolution effectiveness. • Deliver QA orientation to agents prior to nesting or production. • Lead weekly calibration sessions with clients to align on scoring standards and ensure consistency. • Respond to and process client-submitted audit requests. • Identify violations or risk areas related to regulatory compliance, data privacy, or internal protocols. • Ensure agent adherence to standard operating procedures, script usage, disclaimers, and escalation processes. • Recommend corrective actions when non-compliance is identified. • Provide timely, constructive, and specific feedback to agents through Scorebuddy or other QA platforms. • Participate in coaching syncs with Team Leaders or Training to align on developmental actions.

• The Quality Assurance & Field Auditor serves as an independent operational auditor responsible for evaluating station performance across all TFG Aviation companies and service lines. • Conduct announced and unannounced operational audits at assigned stations. • Evaluate station performance using standardized audit tools and scoring methodologies. • Perform comprehensive assessments across all operational departments and lines of business. • Validate operational execution against company standards and customer expectations. • Prepare comprehensive audit reports following each station visit. • Partner with operational leaders to improve station performance. • Identify operational risks and escalate significant findings immediately to Service Delivery Leadership.

• Responsible for ensuring case reports are of the highest quality and integrity. • Handle quality assurance questions and provide support to the Quality Assurance Department. • Perform quality assurance review of peer review reports, correspondences, addendums or supplemental reviews. • Ensure clear, concise, evidence-based rationales have been provided in support of all recommendations and/or determinations. • Ensure that all client instructions and specifications have been followed and that all questions have been addressed. • Verify that the peer reviewer has attested to only the facts and that no evidence of reviewer conflict of interest exists. • Assist in resolution of client complaints and quality assurance issues as needed.