Edward Markarian

IT Systems Manager

Novo Nordisk

Orchestrated enterprise-wide operational risk assessments across regulated platforms, establishing risk mitigation controls aligned with corporate architecture, FDA, and global cGMP standards for a green field expansion project. Collaborated with executive leadership, Quality, and Engineering stakeholders to define operational roadmaps and standardized risk assessment processes.

Risk AssessmentGMPFDA RegulationsVeeva Vault QualityDocsGovernanceStakeholder Management

IT Manager

Managed, coached, and mentored cross-functional delivery leads and engineers, established KPI metrics, conducted performance reviews, and cultivated high-performing teams. Oversaw operational strategy, platform architecture, and system integration across global laboratory, bioinformatics, AWS data archiving, and clinical operations.

Team LeadershipKPI MetricsPerformance ReviewsOperational StrategyPlatform ArchitectureSystem IntegrationAWSBioinformaticsClinical Operations

Senior Software QA Engineer

Managed technical debt resolution and root-cause remediations for complex operations and laboratory platforms. Developed data analysis frameworks and operational dashboards to track area health, performance metrics, and operational risk.

Software QARoot Cause AnalysisData AnalysisDashboardingOperational Risk

Genomics System Validation and Testing Lead

Led end-to-end digital transformation for core platforms, replacing manual paper-based workflows with automated digital systems and centralized SOP libraries. Cleared a critical compliance and technical backlog by testing, modernizing, and fully validating 12+ enterprise systems within 12 months.

Systems ValidationDigital TransformationSOP ManagementComplianceTesting

Validation Lead

Gilead Sciences

Directed the architecture, data interface design, and validation strategy for secure integration platforms (Veeva vault) connecting external partner manufacturing to internal systems on an accelerated 12-week timeline. Managed issues, recommended courses of actions, communicated risks, and stakeholder expectations.

Validation StrategyVeeva VaultData InterfaceRisk ManagementStakeholder Communication

Quality Manager / Business Systems Administrator

Managed enterprise Quality QMS architecture, workflow enhancements, change control strategies, and user access migration during corporate acquisitions. Served as interim project manager for vendors and IT to address and resolve system issues and appropriately communicated gating items to management, Business Process Owners, and users.

QMS ArchitectureChange ControlUser Access MigrationProject ManagementVendor Management

Business Systems Analyst II

Grifols

Performed IT administration, business analysis, and support for corporate Trackwise QMS application, relational databases, and servers for incident/CAPA process.

IT AdministrationBusiness AnalysisTrackWise QMSRelational DatabasesCAPA

Senior Quality Associate II

Provided operational consulting and system architecture support for corporate QMS applications, Oracle/SQL databases, and manufacturing server infrastructure. Strengthened compliance by advocating changes to corporate SOPs to address regulatory observations and served on Change Advisory Boards.

QMSOracleSQLManufacturing InfrastructureSOPsChange Advisory Board

Project Manager

Managed cross-functional engineering teams delivering operational strategy, validation, and consulting for global pharmaceutical and biotechnology clients, driving 25-30% annual growth. Managed direct reports consisting of a team of nine engineers and performed performance reviews, contract proposal generation, and HR support.

Project ManagementTeam LeadershipValidationConsultingPerformance ReviewsContract Proposals

Senior Validation Engineer

Executed qualification and testing protocols for laboratory systems, utilities, IT infrastructure, and automated manufacturing control systems. Managed projects for multiple pharmaceutical and biotechnology clients which led to promotion to project manager.

Qualification ProtocolsTestingLaboratory SystemsIT InfrastructureManufacturing Systems