Acceptance Testing, Advertising Operations, Analysis Skills, Audit Metrics, Auditing, Automation, Best Practices, Biotech and Pharmaceutical, Business Analysis, Business Growth, Business Intelligence, Business Operations, Business Processes, Business Support, Center For Drug Evaluation and Research (CDER), Cloud Computing, Continuous Improvement, Corrective Action, Customer Relations, Customer Relationship Management (CRM), Data Analysis, Data Migration, Data Quality, Decision Support, Documentation, Executive Assistant Skills , FDA (Food and Drug Administration), Leadership, Metrics, Operational Audit, Operational Support, Operations Management, Performance Metrics, Power BI, Process Improvement, Product Demonstration, Proposal Development, Quality Management, Quality Metrics, Reconciliation, Regulations, Regulatory Compliance, Reporting Dashboards, Reporting Skills, Requirements Management, Risk Management, Salesforce.com, Scorecarding, Systems Administration/Management, Tableau, Technical Presentation, Trend Analysis, Vendor/Supplier Management
To acquire the advantage, Zolon PCS is seeking a Reports & Analytics Configuration. This program will replace multiple decentralized and legacy quality management environments with a single, enterprise-wide platform that supports quality, compliance, training, audits, risk management, equipment management, supplier management, and corrective action processes across FDA Centers and Offices. The solution will support FDA organizations, including the Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Human Food Program (HFP), Office of the Chief Scientist (OCS), Office of Inspections and Investigations (OII), and other FDA quality organizations.
Job Description:
Design, develop, configure, and maintain dashboards, scorecards, analytics solutions, executive dashboards, and operational reports supporting enterprise Quality Management System (QMS) operations within ComplianceQuest and Salesforce GovCloud.
Collaborate with business stakeholders, quality teams, program leadership, and system users to define key performance indicators (KPIs), reporting requirements, compliance metrics, audit indicators, training metrics, and executive reporting needs.
Develop recurring, ad hoc, operational, management, regulatory, and audit-support reports to support FDA business processes, quality programs, and organizational objectives.
Ensure data accuracy, consistency, integrity, and reporting standardization across FDA Centers and stakeholder organizations through validation, reconciliation, and reporting quality reviews.
Analyze business and operational data to identify trends, performance issues, compliance risks, process improvement opportunities, and actionable insights for leadership decision-making.
Configure and optimize Salesforce and ComplianceQuest reporting capabilities, including dashboards, visualizations, report automation, scorecards, and KPI tracking mechanisms.
Support enterprise reporting frameworks, data governance initiatives, report catalog management, and standardized reporting methodologies.
Collaborate with business analysts, developers, system administrators, data migration specialists, and quality teams to ensure reporting solutions align with business requirements and approved data sources.
Support report validation, user acceptance testing (UAT), release readiness activities, and post-deployment support for reporting and analytics enhancements.
Prepare report specifications, dashboard documentation, data definitions, reporting procedures, and user guidance materials to support ongoing operations and audit readiness.
Provide subject matter expertise for proposal development, technical solutioning, customer demonstrations, oral presentations, technical exchanges, and capability briefings.
Contribute lessons learned, best practices, reusable reporting assets, and organizational knowledge artifacts to support continuous improvement and business growth initiatives.
Support development of innovative analytics and reporting solutions based on experience gained through the FDA Cloud QMS Program and collaborate with corporate leadership to expand ComplianceQuest, Salesforce GovCloud, and Quality Management service offerings.
Represent the organization professionally during interactions with customers, partners, regulators, and industry stakeholders.
Requirements:
Experience building and maintaining Salesforce reports, dashboards, scorecards, and analytics solutions.
Experience defining and developing quality management metrics, compliance indicators, operational KPIs, and executive reporting solutions.
Experience gathering reporting requirements and translating business needs into actionable dashboards, reports, and analytics capabilities.
Experience performing data analysis, trend analysis, reporting validation, and data quality reviews.
Experience supporting executive reporting requirements and leadership decision-support initiatives.
Experience designing enterprise reporting frameworks, reporting standards, and governance processes preferred.
Experience with ComplianceQuest reporting capabilities and Quality Management System (QMS) reporting preferred.
Experience with Tableau, Power BI, CRM Analytics (Einstein Analytics), or similar business intelligence platforms preferred.
Strong analytical, documentation, communication, and stakeholder engagement skills.
Prior FDA experience is highly desirable.
Bachelor's degree desired.
Clearance: Ability to obtain Public Trust tier 2
Location: White Oak, Maryland (Hybrid)