Senior CSV Consultant: Life Sciences & Compliance

Infosys Consulting; Indianapolis (IN); On-site; USD 130,000 - 170,000; Full time

Benefits offered by this job

Disability benefits

Health reimbursement accounts

Insurance (various)

401(k) plan

Job summary

Infosys Consulting seeks a Senior Consultant in the Life Sciences domain to lead Computerized System Validation efforts for IT systems. You will drive validation deliverables, ensure regulatory compliance, and collaborate with cross-functional teams across validation, security, and project management disciplines.

The role emphasizes audit support, risk management, and continuous improvement within Agile and Waterfall delivery models, with location options including Indianapolis.

Qualifications

• 5+ years of professional experience in Life Sciences consulting.
• Knowledge of 21 CFR Part 11, GxP, and GAMP 5.
• Experience creating, reviewing and approving validation deliverables.
• Knowledge of risk management processes.
• Thorough knowledge of compliance and validation concepts.
• Proven ability to support multiple projects in complex environments.
• IT background preferred to understand program complexities.

Responsibilities

• Create, review, and approve validation deliverables.
• Define IT system development processes following Agile methods and ensure compliance in each release/Iteration.
• Work with Agile/JIRA, Confluence, ALM.
• Author major project validation deliverables as per SOPs.
• Review and approve system lifecycle deliverables.
• Guide project teams on validation, security, and project management deliverables.
• Advise on compliance and security controls at development stages.
• Contribute to audits, assessments, or inspections.
• Escalate critical compliance findings and risks to client units.
• Prepare management reports on compliance operations and progress.

Skills

Pharma compliance

Agile & Waterfall

Multi-project mgmt

Communication skills

Tools

ServiceNow

JIRA

Veeva

HPALM

Job description

Infosys Consulting seeks a Senior Consultant in the Life Sciences domain to lead Computerized System Validation efforts for IT systems. You will drive validation deliverables, ensure regulatory compliance, and collaborate with cross-functional teams across validation, security, and project management disciplines.

The role emphasizes audit support, risk management, and continuous improvement within Agile and Waterfall delivery models, with location options including Indianapolis.