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 with industry regulations and providing technical expertise to support life sciences customers.
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
- Variable bonus and/or stock bonus
Company Overview
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