Veeva is a mission-driven organization that aspires to help our customers in Life Sciences and Regulated industries bring their products to market, faster. We are shaped by our values: Do the Right Thing, Customer Success, Employee Success, and Speed. Our teams develop transformative cloud software, services, consulting, and data to make our customers more efficient and effective in everything they do. Veeva is a work anywhere company. There are options for working from home, at a customer site, or in an office on any given day. As a Public Benefit Corporation, you will also work for a company focused on making a positive impact on its customers, employees, and communities.
The Validation Lead provides Computer Systems Validation support to the Quality and Compliance function in support of Veeva’s clinical product suite. Primarily responsible for supporting the ongoing validation activities across the Vault products, including general releases and patches/hot-fixes. Drive the computer validation/qualification activities including developing/executing CSV deliverables (Business/Functional Requirements, Risk Assessments, Validation Plans/ Protocols, IQ, OQ, Validation Summary) to completion. Provide technical validation expertise, interpretation, and direction to assure compliance with GxP (GMP, GCP, Device) regulatory requirements, company policies, and standards regarding validation, document control, and change management.
What You'll Do
- 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 in regards to computer validation, federal regulations, and other quality system requirements.
- Closely collaborate with Product Managers to ensure requirements/specifications are defined in a clear, testable, and compliant 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.
- Bachelor’s degree in Engineering/ Sciences or equivalent relevant technical experience
- At least 5+ years of experience in CSV role.
- Hands-on experience with the validation of enterprise applications in the Life Sciences such as eTMF, QMS (CAPA, Training, etc.), CTMS, Regulatory Filing systems used in the conduct of regulated activities.
- Good understanding of ERES regulations (e.g., 21 CFR Part 11), GCPs (e.g. ICH E6)
- Knowledge of Agile software development, and software testing methodologies.
- Excellent written and oral communication skills, good decision-making skills, and time management skills.
Nice to Have
- Experience with cloud-based applications, mobile applications and/or infrastructure compliance
- Understanding of Agile development methodology
- 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.