Strategic Business Systems Analyst - Data & GxP Med Devices

Coforge; Indianapolis (IN); On-site; USD 90,000 - 130,000; Full time

Job summary

Coforge, Indianapolis, is seeking a Business System Analyst with Delivery, Devices, & Connected Solutions (DDCS) to translate complex business needs into actionable data and system requirements. You will gather stakeholder input, map processes, and document data flows across multiple systems.

The role emphasizes data governance, GxP compliance, and collaboration with data architects, SMEs, and engineering teams to ensure traceability, V&V, and timely delivery within an Agile framework.

Qualifications

• 5+ years in Business Analysis, Systems Analysis, or Data Analysis.
• Experience in Requirements Gathering, Process Mapping, and Gap Analysis.
• Proven ability to document Data Flow Diagrams and RTMs.
• Strong stakeholder management and workshop facilitation.
• Experience in Pharma, Biotech, Medical Device, or Life Sciences.
• Knowledge of GxP, ALCOA+, V&V, DHF, FMEA, CTD, and BLA processes.
• Experience with LIMS, ELN, PLM, and Document Management Systems.
• Understanding of Data Governance, Data Architecture, and Data Migration.
• Familiarity with Bronze, Silver, and Gold Data Layers.
• Agile/Scrum methodologies and backlog management.
• Excellent documentation, communication, and analytical skills.
• Certifications: CBAP/ PMI-PBA preferred.

Responsibilities

• Gather and document business and data requirements from stakeholders.
• Conduct process mapping, workflow analysis, and gap analysis.
• Create data flow diagrams, data dictionaries, and RTMs.
• Collaborate with data architects, SMEs, and engineering teams.
• Analyze data movement across systems and identify improvements.
• Support data governance, GxP compliance, DHF, and V&V.
• Evaluate ELN, LIMS, PLM, and related systems.
• Facilitate stakeholder meetings and manage requirement traceability.
• Present findings and project artifacts to leadership.

Skills

Stakeholder Management

Data Flow Mapping

Gap Analysis

Data Governance

ALCOA+

GxP Compliance

Medical Device

Agile/Scrum

Documentation

Tools

LIMS

ELN

PLM

Document Management Systems

Job description

Coforge, Indianapolis, is seeking a Business System Analyst with Delivery, Devices, & Connected Solutions (DDCS) to translate complex business needs into actionable data and system requirements. You will gather stakeholder input, map processes, and document data flows across multiple systems.

The role emphasizes data governance, GxP compliance, and collaboration with data architects, SMEs, and engineering teams to ensure traceability, V&V, and timely delivery within an Agile framework.