Director - Computer Systems Validation
V
Veeva SystemsLife sciences software
Source API remote eligibility restrictions: United StatesFull-TimeDirector
Salary150,000 - 230,000 USD per year
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Job Details
- Experience
- 10+ years of directly relevant experience; previous managerial experience (5+)
- Required Skills
- Project ManagementGCP
Requirements
- Bachelor’s degree in engineering, sciences, a related discipline, or equivalent, with applicable industry experience.
- 10+ years of directly relevant experience validating enterprise software and computer information systems in regulated life sciences environments.
- 5+ years of managerial experience, including team selection, motivation, retention, personnel management, and financial-resource planning.
- Hands-on experience or working knowledge of risk-based validation, compliance frameworks, and governance for AI/ML-enabled capabilities in life sciences software.
- Demonstrated understanding of ERES regulations, including 21 CFR Part 11.
- Applied GCP experience, such as ICH E6 or 21 CFR 56, and GMP experience, such as 21 CFR 211 or 21 CFR 820.
- Experience using or developing risk-based, critical-thinking decision models for validation activities.
- Excellent project management, communication, and technical writing skills.
- Ability to work in a matrix environment and lead cross-functional, multi-level teams.
- Nice to have: exposure to Agile SDLC, SaaS, AI, cloud technologies, automated testing, global health authorities, and frameworks such as ISO, SEI, or ITIL.
Responsibilities
- Manage and mentor validation program managers and team leads on projects for Veeva and internal business systems.
- Deliver validation projects to deadlines and review and approve validation approaches, methods, and reports for periodic software releases.
- Establish risk-appropriate validation processes and coordinate complex validation projects with customers, collaborators, and quality teams.
- Oversee on-shore and off-shore validation contractors to meet defined budgets and timelines.
- Represent validation in discussions with Product Development, Operations, Security, and Quality Assurance/Compliance.
- Support planning and execution of product and internal-system periodic reviews.
- Present computer systems validation operations during customer audits.
- Execute other projects and duties to support compliance across Veeva products and internal business systems.
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