Validation Lead, Vault

Quality, Security, & Compliance Pleasanton, California


Company Information

Be a part of the future of cloud at one of the fastest growing and profitable companies in enterprise software. Veeva is experiencing rapid growth and strong demand as the cloud software market is evolving toward industry-specific, cloud solutions. Veeva topped the Fortune Future 50 list of U.S. companies poised for breakout growth and was listed as one of the fastest growing companies among Forbes Fast Tech 25.

We build innovative SaaS solutions that span CRM, content management, and data for the life sciences industry. Our more than 675 customers ranging from emerging biotechs to the largest global pharmaceutical companies including Bayer, Lilly, Merck, and Novartis.

We are driven by our core values: do the right thing, employee success, customer success, and speed. We are innovators, collaborators, and thought leaders out to create and bring to market solutions that help our customers improve and extend human life.

Job Summary

The Validation Lead provides Computer Systems Validation support to the Quality and Compliance function in support of Veeva product validation. 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, PQ) to completion. Provide technical validation expertise, interpretation and direction to assure compliance with regulatory requirements, company policies and standards.

Responsibilities

  • 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.
Requirements
  • Bachelor’s degree in Engineering/ Sciences or equivalent relevant experience
  • 7-9 years experience in CSV role.
  • Hands-on experience with the validation of enterprise applications in the Life Sciences such as EDMS, CTMS, eTMF, Training/Learning Management System (LMS), and/or Quality Information Systems (e.g., Change Control, CAPA)
  • Good understanding of 21 CFR Part 11, GCPs and principles of computer validation.
  • 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

We don’t accept candidates from recruiters or placement agencies. If you have a candidate interested in Veeva, they should apply directly below or at careers@veeva.com. For more information regarding this policy click here.