Director - Computer Systems Validation

About the role

Veeva Systems, a life sciences cloud software company, is hiring a Director of Computer Systems Validation in Toronto. The role supports the Quality, Regulatory and Compliance function in qualifying Veeva Vault technology, overseeing validation teams and their delivery of validation activities for general releases and patches.

Key responsibilities

• Oversight of validation teams to deliver validation activities on time and on budget, including periodic reviews and new product introductions, and mentoring of team leaders on GxP compliance
• Advancing modern validation practices, including test automation and governance of AI-driven capabilities
• Supporting audit management by presenting CSV operations during customer audits
• Managing validation projects for Veeva and internal business systems, approving validation approaches and reports (VPP, VIA, VSR)
• Overseeing onshore and offshore validation contractors and acting as the link between Product Development, Operations, Security and Quality Assurance/Compliance

Required profile

• B.S. in engineering, science or a related field, or equivalent, with 10+ years of validation experience in enterprise software and computer information systems in a life sciences regulated environment (GMP, GCP, GLP, GvP)
• 5+ years of managerial experience selecting, motivating and retaining a team and managing personnel and financial resources
• Demonstrated understanding of ERES regulations (e.g. 21 CFR Part 11) and applied experience in GCPs and GMPs (e.g. ICH E6, 21 CFR 56, 21 CFR 820)
• Proven ability to lead cross-functional teams in a matrix environment

Required skills

• Risk-based validation, compliance frameworks and governance of AI/ML-enabled capabilities
• Excellent project management, communication and technical writing skills
• Nice to have: Agile SDLC, SaaS, AI, IT cloud, ISO/SEI/ITIL awareness, exposure to global health authorities, and automated testing technologies

What we offer

• Base pay of $180,000 - $230,000 CAD, with possible bonus and/or stock bonus
• Medical, dental, vision and basic life insurance, PTO and company-paid holidays
• Retirement programs and a 1% charitable giving program
• Flexible work from home or in the office