Computer System Validation Lead / Program Manager en Veeva

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $3B in revenue in our last fiscal year with extensive growth potential ahead.

 

At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company – we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors.

 

As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment.

 

Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities.

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.

This is a work anywhere, full-time permanent role with Veeva. Our work processes are designed so that you can be productive in the environment that works best for you. 

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

Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.

 

Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances. If you need assistance or accommodation due to a disability or special need when applying for a role or in our recruitment process, please contact us at [email protected].