Director - Computer Systems Validation

Openkrill; United States; Remote; USD 126,000 - 161,000; Full time

Benefits offered by this job

Medical insurance

PTO and company-paid holidays

Retirement programs

1% charitable giving program

Job summary

Veeva Systems is seeking a Director of the Computer Systems Validation Program to support Quality, Regulatory and Compliance in qualification of Veeva Vault technology. You will oversee validation teams, drive on-time, on-budget delivery, and advance validation practices, including AI-driven capabilities, while ensuring GxP compliance and audit readiness.

You will mentor leaders, coordinate with Product Development, Operations, and Quality Assurance, and manage validation for SaaS products and

Qualifications

• Requires a BS in engineering/sciences or related field and applicable industry experience.
• 10+ years in validation of enterprise software in life sciences regulated environments (GMP, GCP, GLP).
• 5+ years of managerial experience in validation teams and budgeting.

Responsibilities

• Lead and mentor validation program managers and team leads to ensure regulatory compliance.
• Deliver validation projects under strict deadlines and approve approaches and reporting.
• Establish risk-based validation processes and coordinate with customers and quality teams.
• Oversee offshore/onsite validation contractors to meet budgets and timelines.
• Interface with executive management across Product Development, Operations, Security, and Quality Assurance.

Skills

Validation leadership

Regulatory knowledge

Risk-based validation

GxP compliance

Project management

Technical writing

Education

BS in engineering/sciences

Tools

Automated testing

AI/ML capabilities

Job description

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $3B in revenue in our last fiscal year with extensive growth potential ahead.

At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company - we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors.

As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment.

Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities.

The Role

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.

What You'll Do

• 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

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 Have

• 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

Perks & 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.

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Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.

Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances. If you need assistance or accommodation due to a disability or special need when applying for a role or in our recruitment process, please contact us at [e-mail].