Acceptance Testing, Auditing, Best Practices, Biology, Biotech and Pharmaceutical, Business Growth, Business Transformation, Center For Drug Evaluation and Research (CDER), Cloud Computing, Code of Federal Regulations, Communication Skills, Computer Systems, Continuous Improvement, Corrective Action, Data Analysis, Data Management, Data Mapping, Data Migration, Data Profiling, Data Quality, Database Extract Transform and Load (ETL), Documentation, FDA (Food and Drug Administration), FDA Requirements, FISMA - Federal Information Security Management Act, GxP, Healthcare Quality, Identify Issues, Informatica, Leadership, Migration Strategy, Process Improvement, Product Demonstration, Proposal Development, Quality Management, Quality Metrics, Reconciliation, Regulations, Regulatory Compliance, Reporting Skills, Risk Management, SQL (Structured Query Language), SQL Server Integration Services (SSIS), Salesforce.com, Scripting (Scripting Languages), ServiceNow, Software as a Service (SaaS), Source Code/Configuration Management (SCM), System Migration, System Validation, Systems Analysis, Team Lead/Manager, Technical Presentation, Test Strategy, Traceability, Vendor/Supplier Management
To acquire the advantage, Zolon PCS is seeking a Data Migration Lead. 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:
Lead planning, governance, and execution of all data migration activities securely from legacy system repositories and source systems into ComplianceQuest operating within Salesforce GovCloud.
Define, manage and test migration strategy, data mapping rules, transformation logic, reconciliation methodologies, validation approaches, migration runbooks, cutover sequencing, rollback procedures, and audit-ready documentation.
Conduct data discovery, profiling, and source-system analysis to identify data quality issues, dependencies, migration risks, and business transformation requirements.
Coordinate migration requirements, business rules, data ownership decisions, and stakeholder approvals across business, quality, technical, and program teams.
Establish data migration standards, controls, and best practices to ensure data integrity, accuracy, completeness, traceability, and regulatory compliance.
Oversee development and execution of ETL processes, conversion scripts, migration tools, mock conversions, migration rehearsals, production cutovers, and post-migration validation activities.
Lead data quality assessments, cleansing, normalization, deduplication, enrichment, and remediation efforts prior to migration.
Ensure migration activities comply with FDA regulations, GxP requirements, FISMA, Zero Trust, 21 CFR Part 11, Computer System Validation (CSV), and organizational quality management standards.
Develop reconciliation reports, validation evidence, traceability documentation, migration reports, and audit-ready artifacts supporting regulatory inspections and quality reviews.
Identify, track, and mitigate migration risks, issues, dependencies, and schedule impacts while providing regular status reporting to project leadership and stakeholders.
Support User Acceptance Testing (UAT), validation activities, release readiness reviews, and production deployment events associated with migrated data.
Provide subject matter expertise for proposal development, technical solutioning, customer demonstrations, oral presentations, technical exchanges, and capability briefings.
Contribute lessons learned, best practices, reusable migration assets, and organizational knowledge artifacts to support continuous improvement and business growth.
Support development of innovative migration accelerators and data management solutions based on experience gained through the FDA Cloud QMS Program.
Collaborate with corporate leadership to expand ComplianceQuest, Salesforce GovCloud, Data Migration, and Quality Management service offerings while representing the organization professionally with customers, partners, and industry stakeholders.
Requirements:
Prior FDA experience strongly desired.
10+ years of enterprise data migration experience.
3+ years leading regulated-system migrations (FDA, GxP, Life Sciences, Healthcare, or Quality Systems) preferred
Experience migrating data into Salesforce, ComplianceQuest, ServiceNow, or similar SaaS platforms.
Experience creating data mapping specifications, reconciliation reports, cutover plans, and rollback strategies.
Strong SQL and data profiling expertise.
Experience with ETL tools (Informatica, Talend, MuleSoft, Boomi, SSIS, Data Loader, etc.).
Experience supporting CSV, validation, and audit activities.
Experience migrating QMS records such as CAPAs, Deviations,Complaints, Change Controls, Audits, Training, Suppliers, and Documents.
Strong stakeholder management and executive communication skills.
Experience leading migration teams and coordinating business, technical, and quality stakeholders..
Bachelor's degree desired.
Clearance: Ability to obtain Public Trust tier 2
Location: White Oak, Maryland (Hybrid)