Computer System Validation Lead / Program Manager

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.
• 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.
• 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
• 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 has been provided to comply with local regulations and represents a potential base salary range for this role. Please note that actual salaries may vary within the range above or below, depending on experience and location. We look at compensation for each individual and base our offer on your unique qualifications, experience, and expected contributions. This position may also be eligible for other types of compensation in addition to base salary, such as variable bonus and/or stock bonus.

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