Computer System Validation Lead​/Program Manager

The Role

Join Veeva as we bring the power of modern, cloud-based digital validation to the industry. As a Computer Systems Validation Lead / Program Manager, you’ll lead the Validation supporting Veeva products (eTMF, CTMS, QMS, LIMS, etc.) – helping life sciences companies speed their adoption of a unified, cloud-based platform leveraging Veeva Validation documentation.

We are seeking an experienced CSV professional to plan and support ongoing validation activities that includes general releases and patches/hot fixes for Veeva’s Quality applications. Drives the computer validation/qualification activities including developing/executing CSV deliverables (Business/Functional Requirements, Risk Assessments, Validation Plans/ Protocols, IQ, OQ, Validation Summary). Provides technical validation expertise, interpretation, and direction to assure compliance with industry and regulatory requirements (e.g., 21

CFR
211, Part 820, Part 11, Annex 11, ICH Q10, etc.), company policies and standards regarding validation, document control and change management.

In this role, you’ll act as a trusted CSV planner, advisor, and partner with other Veeva teams. Through this partnership, you and your Veeva teams will deliver consistent and high‑quality deliverables supporting Veeva life‑sciences customers.

• Lead and execute the validation activities for Veeva’s general releases, hot fixes, and product periodic revalidation.
• Track, monitor, and control the 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.
• Collaborate closely with the Product Team to ensure requirements/specifications are defined in a clear, testable, and compliant format.
• Work with cross‑functional teams (Product Management, SQA, Technical Operations, IT Engineering, etc.) to maintain the validated state of the system.
• 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 prioritize issues early and track validation incidents to closure.
• Ensure clear traceability against all testing performed.
• Create and update CSV deliverables (IQ/OQ, VPP, VSR, Trace Matrices).
• Conduct independent pre‑ and post‑execution review of validation test scripts.
• Coordinate with cross‑functional teams to design and execute test protocols.
• Support change control as a validation technical resource and ensure timely completion of required tasks.
• Perform validation impact analysis and risk assessments in collaboration with product teams.
• Execute other projects or duties as assigned to ensure compliance across Veeva’s product line and internal business systems.

• Bachelor’s degree in Engineering, Sciences or equivalent relevant technical experience.
• At least 3+ years of experience in a CSV role.
• Hands‑on experience with the validation of enterprise applications (e.g., SAP) used in commercial regulated activities (Good Distribution Practice) and/or supporting industry applications (e.g., eTFM, CTMS, LIMS, Quality Management, DCS, etc.).
• Good understanding of industry regulations (e.g., 21
  
  CFR
  11, 21
  
  CFR
  211, 21
  
  CFR
  312, 21
  
  CFR
  203, 21
  
  CFR
  820, etc.) and 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 skills, 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.

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

Base pay: $85,000 – $120,000. The salary range listed here is provided to comply with local regulations and represents a potential base…