CSV Lead & Program Manager – Cloud Validation

Veeva; Boston (MA); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Flexible PTO

Retirement programs

1% charitable giving program

Job summary

Veeva seeks a Computer Systems Validation Lead / Program Manager to drive validation for eTMF, CTMS, QMS, LIMS, and related cloud-based software across releases and patches.

You will plan, execute, and govern CSV deliverables (IQ/OQ, VPP, VSR, risk assessments) ensuring regulatory compliance and end-to-end traceability. Collaborate with Product, SQA, and IT teams to deliver high-quality validation artifacts.

Qualifications

• Bachelor’s degree in Engineering, Sciences or equivalent relevant technical experience.
• 3+ years of experience in a CSV role.
• Hands-on validation of enterprise applications in regulated environments.
• Familiarity with 21 CFR 11 and ISO standards.

Responsibilities

• Lead validation activities for general releases, hot fixes, and revalidations.
• Develop and execute CSV deliverables (IQ/OQ, VPP, VSR, trace matrices).
• Ensure regulatory compliance and traceability across the validation lifecycle.
• Collaborate with Product, SQA, and IT to maintain validated state of systems.

Skills

CSV

Regulatory knowledge

Risk assessment

Test planning

Agile methods

Communication

Traceability

Education

Bachelor’s degree in Engineering/Sciences

Tools

SAP

eTMF

CTMS

LIMS

QMS

DCS

Job description

Veeva seeks a Computer Systems Validation Lead / Program Manager to drive validation for eTMF, CTMS, QMS, LIMS, and related cloud-based software across releases and patches.

You will plan, execute, and govern CSV deliverables (IQ/OQ, VPP, VSR, risk assessments) ensuring regulatory compliance and end-to-end traceability. Collaborate with Product, SQA, and IT teams to deliver high-quality validation artifacts.