Senior Business Analyst (R&D)

The Role

Cognizant is seeking a Senior Business Analyst – Laboratory Systems to lead business analysis activities supporting the design, implementation, and validation of modern laboratory environments. In this role, you will partner closely with business stakeholders, IT, Quality, and vendors to ensure laboratory systems and processes meet business needs while complying with regulatory, data integrity, and Computer System Validation (CSV) requirements.

You will play a critical role in aligning business requirements, regulatory expectations, and technical solutions across GxP‑regulated laboratory operations.

Key Responsibilities

Business & Regulatory Requirements

• Elicit, analyze, and document business and functional requirements through stakeholder interviews and facilitated workshops
• Author and maintain key deliverables, including BRD, URS, FRS, and RTM
• Ensure adherence to ALCOA+ data integrity principles and applicable regulatory requirements

Process Analysis & Improvement

• Assess current laboratory operations and workflows
• Develop As‑Is and To‑Be process maps
• Identify opportunities for process optimization, standardization, and risk reduction

Solution & Impact Assessment

• Support feasibility and impact analysis for proposed IT and laboratory solutions
• Evaluate implications of system, process, or configuration changes
• Ensure alignment between business needs, compliance expectations, and technical design

Laboratory Systems Implementation Support

• Support implementations and enhancements of laboratory systems such as LIMS, CDS, ELN, Empower, and laboratory instrumentation
• Assist with system configuration, integrations, and interface requirements

Stakeholder Communication & Collaboration

• Act as a liaison between business users, IT teams, Quality, and external vendors
• Drive alignment on objectives, scope, and issue resolution across project teams

Project & Validation Support

• Contribute to project planning, tracking, and status reporting
• Support validation strategy development, planning, and execution activities

GxP Compliance & CSV

• Author and review validation documentation in alignment with CSV lifecycle expectations
• Maintain requirement traceability throughout the project lifecycle
• Support audit readiness, inspections, and change control activities

Vendor & Cross‑Functional Coordination

• Collaborate with lab engineers, QA, system integrators, and vendors
• Review vendor documentation to ensure suitability for GxP‑regulated environments

Risk & Data Integrity Management

• Participate in risk assessments to identify compliance and data integrity risks
• Identify, assess, and help mitigate data integrity vulnerabilities

Data Migration & Infrastructure Support

• Define data migration and data retention requirements
• Support strategies for backups, archival, audit trails, and data availability

Required Qualifications

• Bachelor’s degree or equivalent practical experience
• Extensive experience supporting GxP‑regulated laboratory environments as a Business Analyst
• Strong knowledge of CSV, data integrity, and regulatory compliance
• Experience with laboratory systems such as LIMS, CDS, ELN, Empower, or similar platforms
• Proven ability to lead stakeholders and translate business needs into clear, compliant documentation

Preferred Qualifications

• Experience supporting laboratory modernization or new lab build initiatives
• Familiarity with FDA, EMA, and global regulatory expectations
• Consulting or multi‑client delivery experience

Work Model

Hybrid role based in Foster City, CA, with on‑site presence required per project and client needs.

Equal Opportunity Statement

Cognizant is an equal opportunity employer and committed to creating a diverse and inclusive workforce.