[Remote] Computer System Validation Lead / Program Manager

Note: The job is a remote job and is open to candidates in USA. Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As a Computer Systems Validation Lead / Program Manager, you will lead validation activities for Veeva products, ensuring compliance and quality in the validation process.


Responsibilities

  • Lead and execute (as needed) the validation activities for Veeva’s general releases, hot fixes, as well as product periodic revalidation
  • Responsible for tracking, monitoring, and controlling validation process to ensure timely delivery to meet pre-scheduled release dates and budgets
  • Provide technical expertise, regulatory interpretation, and direction regarding computer validation, federal regulations, and other quality system requirements
  • Closely collaborate with Product Team to ensure requirements/specifications are defined in a clear, testable, and compliant format
  • Effectively work with cross functional teams (Product Management, SQA, Technical Operations, IT Engineering, etc.) to ensure the validated state of the system is maintained
  • Ensure requirements are adequately tested following a risk-based approach
  • Identify and log issues found during validation execution. Work closely with Product and SQA teams to identify and prioritize issues early on and track validation incidents to closure
  • Ensure clear traceability against all testing performed
  • Create/update CSV deliverables including IQ/OQ, VPP, VSR, Trace Matrices
  • Independent pre and post execution review of validation test scripts
  • Coordinate with cross-functional teams to design and execute test protocols
  • Supports change control as validation technical resource and ensures timely completion of required tasks
  • Perform validation impact analysis and risk assessments in conjunction with product teams
  • Execute other projects/duties as assigned to ensure compliance across Veeva’s product line and internal business systems

Skills

  • Bachelor's degree in Engineering/ Sciences or equivalent relevant technical experience
  • At least 3+ years of experience in CSV role
  • Hands-on experience with the validation of enterprise applications (e.g., SAP) used in the conduct of commercial regulated activities (Good Distribution Practice) and / or supporting industry applications (e.g., eTFM, CTMS, LIMS, Quality Management, DCS, etc.)
  • Good understanding of the relevant industry regulations (e.g., 21CFR11 / Annex 11, 21CRF211, 21CFR312, 21CFR203, 21CFR820, etc.) as well as industry standards /principles (ISO 9001, ASTM E2500, ISPE Baseline Guides)
  • Familiarity with Agile software development, business analysis and/or software testing methodologies
  • Excellent written and oral communication skill, good decision-making skills and time management skills
  • Experience with cloud-based applications, mobile applications and/or infrastructure compliance
  • Understanding of Agile development methodology
  • Understanding of CSA, RBV, use and Validation of AI in the life-sciences
  • Working knowledge of GAMP 5

Benefits

  • Medical, dental, vision, and basic life insurance
  • Flexible PTO and company paid holidays
  • Retirement programs
  • 1% charitable giving program

Company Overview

  • Veeva delivers the industry cloud for life sciences with software, AI, data, and business consulting. It was founded in 2007, and is headquartered in Pleasanton, California, USA, with a workforce of 5001-10000 employees. Its website is

    • Company H1B Sponsorship

  • Veeva Systems has a track record of offering H1B sponsorships, with 27 in 2026, 100 in 2025, 56 in 2024, 50 in 2023, 73 in 2022, 55 in 2021, 38 in 2020. Please note that this does not guarantee sponsorship for this specific role.

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