Director - Computer Systems Validation
About The Position
The Director of Computer Systems Validation Program provides support to the Quality, Regulatory and Compliance function in support of qualification of Veeva Vault technology. Primarily responsible for oversight of the assigned Validation teams to ensure on-time, on-budget delivery of computer system validation activities supporting general releases and patches/hot fixes. Plan and drive complex validation tasks (periodic review, new product introduction) across the Validation teams while advancing modern validation practices, including test automation strategies and the governance and validation of AI-driven capabilities. Mentor and develop leaders of the assigned Validation teams providing 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. Additional responsibility is to support the audit management function by presenting CSV operations during customer audits.
Requirements
- Knowledge of Software Engineering and Quality Assurance generally attained through studies resulting in a B.S., in engineering/sciences, a related discipline, or its equivalent and applicable industry experience
- 10+ years of directly relevant experience in validation of enterprise software, computer information systems used in life sciences regulated environment (GMP, GCP, GLP, GvP)
- Hands-on experience or working knowledge of risk-based validation, compliance frameworks, and governance for AI/ML-enabled capabilities in life sciences software
- Previous managerial experience (5+) which demonstrates proficiency in selection, motivating and retaining a superior team, effectively managing personnel issues and planning and administering financial resources
- Demonstrated understanding of ERES regulations (e.g., 21 CFR Part 11, etc.)
- Applied experience (i.e., through validation activities, audit support, and/or software system/software product compliance evaluation) in GCPs (e.g., ICH E6, 21 CFR 56, etc.), GMPs (e.g., 21 CRF 211, 21 CFR 820, etc.)
- Use and/or development of risk-based, critical thinking decision-making models to inform validation related activities
- Excellent project management, communication, and technical writing skills are required
- The successful candidate will possess the professionalism and technical competency required to represent the department before our customers, regulatory agencies, and management
- Proven ability working in a matrix environment and leading multi-level / cross functional teams to achieve the highest performance in meeting site and departmental objectives
Nice To Haves
- Exposure to Agile SDLC, SaaS, AI, and/or IT cloud technologies
- Awareness of various global standard frameworks such as ISO, SEI, ITIL
- Exposure to global Health Authorities (e.g., FDA, EMA, Health Canada, MHRA, etc.) with respect to computer system validation & data integrity
- Experience with automated testing technologies
Responsibilities
- Manage/mentor a validation team of validation program managers / team leads (direct reports) on validation projects of Veeva and internal business systems to ensure deliverables conform to company and regulatory requirements
- Responsible to deliver validation projects under strict deadlines to ensure customer success.
- Review and approve validation approach, method, and reporting (VPP, VIA, VSR) during periodic releases of Veeva software products
- Establish validation processes commensurate with the level of risk and manage the execution of validation projects whose scope, regulatory visibility, schedule requirements, and complexity require coordination with customers, collaborators, and quality
- Oversee on-shore and off-shore team of validation contractors testing of Veeva products to ensure deliverables conform to defined budgets and timelines
- Act as executive management interface between Product Development, Operations, Security, and Quality Assurance/Compliance regarding Computer Systems validation exigencies and problem resolution
- Support planning and execution of product and internal system periodic reviews
- Execute other projects/duties as assigned to ensure compliance across Veeva’s product line and internal business systems
Benefits
- Medical, dental, vision, and basic life insurance
- Flexible PTO and company paid holidays
- Retirement programs
- 1% charitable giving program
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What This Job Offers
Job Type
Full-time
Career Level
Director
