Computer Systems Validation Lead

Description: The Validation Lead provides Computer Systems Validation support to the Quality and Compliance function in support of Veeva product validation. Primarily responsible for supporting the ongoing validation activities across multiple product lines, general releases and patches/hot fixes. Interaction with internal customers will be inherent to this position as well as the ability to problem solve and prioritize activities to meet project deadlines. Drive the computer validation/qualification activities including developing/executing software SDLC (Software Development Life Cycle) documents (Business/Functional Requirements, Risk Assessments, IQ, OQ, PQ) to completion. Provide technical validation expertise, interpretation and direction to assure compliance with regulatory requirements, company policies and standards. Responsibilities

• Lead and execute (as needed) the validation activities for Veeva implementation and general releases, hot-fixes, product re-baselines
• Responsible for tracking, monitoring and controlling validation process to ensure timely delivery to meet pre-scheduled release dates
• Provide technical expertise, interpretation and direction in regards to computer validation, federal regulations and other quality requirements.
• Work with Product Managers to ensure requirements/specifications are defined in a clear, testable format
• Effectively work with cross functional teams (Product Management, SQA, Technical Operations) 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
• Coordinates 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.