[Hiring] Director - Computer Systems Validation @Veeva Systems

Role Description

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.
• Support the audit management function by presenting CSV operations during customer audits.

Qualifications

• 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 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.

Requirements

• 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.

Benefits

• Medical, dental, vision, and basic life insurance.
• PTO and company-paid holidays.
• Retirement programs.
• 1% charitable giving program.

Compensation

Base pay: $180,000 - $230,000 CAD. The salary range listed here has been provided to comply with local regulations and represents a potential base salary range for this role. Please note that actual salaries may vary within the range above or below, depending on experience and location. We look at compensation for each individual and base our offer on your unique qualifications, experience, and expected contributions. This position may also be eligible for other types of compensation in addition to base salary, such as variable bonus and/or stock bonus.