Senior Compliance Analyst

DSCSA Analyst IIPosition summaryThe DSCSA Compliance Analyst supports the organization's adherence to the Drug Supply Chain Security Act (DSCSA) and related FDA regulations. This role is responsible for monitoring serialization data, managing trading partner compliance, investigating product verification exceptions, and supporting audit readiness across the pharmaceutical supply chain.Key responsibilitiesMonitor and manage DSCSA transaction data (TI, TH, TS) exchange with manufacturers, wholesalers, and dispensers in compliance with FDA requirements.Investigate and resolve product verification exceptions and serialization discrepancies in the EPCIS system and trading partner portals.Maintain and update trading partner profiles, authorized trading partner (ATP) documentation, and compliance records.Support suspect product and illegitimate product (SPIP) investigations, including quarantine procedures and FDA notification workflows.Generate and review compliance metrics and KPIs; prepare reports for internal stakeholders and regulatory submissions.Collaborate with IT, warehouse, and quality teams to ensure serialization systems and track-and-trace platforms are functioning correctly.Assist in the maintenance of DSCSA SOPs, training materials, and corrective action plans (CAPAs).Stay current on FDA DSCSA guidance updates, industry standards (GS1, EPCIS 1.2/2.0), and interoperability requirements as timelines evolve.Required qualificationsBachelor's degree in pharmacy, life sciences, supply chain, regulatory affairs, or a related field.2–3 years of experience in pharmaceutical supply chain compliance, DSCSA operations, or regulatory affairs.Working knowledge of DSCSA requirements including serialization, EPCIS, lot-level tracing, and interoperability standards.Experience with track-and-trace or serialization platforms (e.g., LSPedia, rfxcel, or similar).Strong analytical and data management skills; comfortable working with large datasets and compliance reports.Proficiency in Microsoft Excel and/or data visualization tools (Power BI) for reporting.Preferred qualificationsFamiliarity with GS1 standards, SGTIN, SSCC, and EPCIS 1.2 implementation.Certification or coursework in regulatory affairs (RAC) or supply chain compliance.Prior experience at a manufacturer, wholesale distributor, or third-party logistics provider (3PL) in a pharmaceutical setting.