Validation Lead, CRM
At 2,200 employees and growing, and consistently strong financials (NYSE:VEEV), Veeva was named among the top fastest growing public technology companies on Forbes’ annual Fast Tech 25 list. We build innovative cloud solutions for some of the world’s largest pharmas and biotechs, and we need great people like you to make it happen.
Our Culture & People
Our core values are Employee Success, Customer Success, and Speed. We are innovators, collaborators, and thought leaders out to create best-in-class solutions that help our customers improve and extend human life. It’s genuine, straight-forward, and no fuss.
The Commercial CRM Validation Lead provides Computer Systems Validation support to the Quality and Compliance function in support of Veeva’s commerical product lines (including CRM, PromoMats, MedComms, Multichannel etc.).
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) to completion. Provide technical validation expertise, interpretation and direction to assure compliance with commercial regulatory requirements, company policies and standards.
- Lead and execute (as needed) the validation activities for Veeva’s 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
- Bachelor’s degree in Engineering/ Sciences or equivalent relevant experience
- 3-5 years experience in CSV role
- Hands-on experience with the validation of commercial enterprise applications such as CRM (e.g. Veeva CRM, SFDC), ERP (SAP) systems
- Solid foundation of the SalesForce.com (SFDC) Platform, including administration, configuration and testing
- Good understanding of 21 CFR Part 11, 203, PDMA (Sample Management and Sample Distribution) and good distribution practice regulations in both US and EU
- Knowledge of Agile software development, and software testing methodologies
- Excellent written and oral communication skill, good decision making skills and time management skills
Nice to Have
- Experience with cloud based applications and/or infrastructure compliance
- Understanding of Agile development methodology
- Working knowledge of GAMP 5
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.
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