Computer System Validation Lead / Program Manager

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 (e.g., 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., 21CFR211, 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 (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.