Veeva Systems

Builds cloud software for life sciences

Director Computer Systems Validation

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeToronto, ON, Canada

About the Job

Requirements

Knowledge of software engineering and quality assurance generally attained through studies resulting in a B.S. in engineering/sciences, a related discipline, or equivalent, together with applicable industry experience.
At least 10 years of directly relevant experience validating enterprise software and computer information systems used in regulated life sciences environments, including GMP, GCP, GLP, or GvP.
Hands-on experience or working knowledge of risk-based validation, compliance frameworks, and governance for AI/ML-enabled capabilities in life sciences software.
At least 5 years of prior managerial experience demonstrating proficiency in selecting, motivating, and retaining a strong team, managing personnel issues, and planning and administering financial resources.
Demonstrated understanding of electronic records and electronic signatures regulations, such as 21 CFR Part 11.
Applied experience through validation activities, audit support, and/or software system or product compliance evaluation in GCPs, such as ICH E6 and 21 CFR 56, and GMPs, such as 21 CFR 211 and 21 CFR 820.
Use and/or development of risk-based, critical-thinking decision-making models to inform validation-related activities.
Project management, communication, and technical writing skills.
Professionalism and technical competency to represent the department before customers, regulatory agencies, and management.
Ability to work in a matrix environment and lead multilevel, cross-functional teams to meet site and departmental objectives.

Responsibilities

Oversee assigned validation teams to deliver computer system validation activities on time and within budget for general releases, patches, and hot fixes.
Plan and drive complex validation tasks, including periodic reviews and new product introductions, across validation teams while advancing modern validation practices, test automation strategies, and governance and validation of AI-driven capabilities.
Mentor and develop leaders of assigned validation teams by providing technical validation expertise, interpretation, and direction to ensure compliance with GxP regulatory requirements, company policies, and standards for validation, document control, and change management.
Present computer systems validation operations during customer audits as part of supporting the audit management function.
Manage and mentor direct-report validation program managers and team leads on Veeva and internal business-system validation projects to ensure deliverables meet company and regulatory requirements.
Deliver validation projects under strict deadlines and review and approve validation approaches, methods, and reports (VPP, VIA, VSR) during periodic releases of Veeva software products.
Establish risk-commensurate validation processes and manage validation projects requiring coordination with customers, collaborators, and quality because of their scope, regulatory visibility, schedule requirements, or complexity.
Oversee onshore and offshore validation contractors testing Veeva products to ensure deliverables meet defined budgets and timelines.
Serve as the executive management interface among Product Development, Operations, Security, and Quality Assurance/Compliance for computer systems validation issues and problem resolution.
Support planning and execution of periodic reviews of products and internal systems.
Execute other assigned projects and duties to ensure compliance across Veeva’s product line and internal business systems.

Desired Qualifications

Exposure to Agile software development lifecycle, SaaS, AI, and/or IT cloud technologies.
Awareness of global standard frameworks such as ISO, SEI, and ITIL.
Exposure to global health authorities, such as FDA, EMA, Health Canada, and MHRA, regarding computer systems validation and data integrity.
Experience with automated testing technologies.

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

Interviewing with Veeva

We value your time and believe in a transparent hiring process. Here is the process you can expect.

Follow the application process and submit your resume.

If moving to the interview stage, our process is as follows:

A conversation with the hiring manager
A personality assessment (unless you have already completed it with Veeva previously)
A practical case exercise
A final conversation with our group's Senior Leader

Once all interviews are complete, the manager will be in touch with a final decision.

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 [email protected].

About the Company

Veeva Systems

Builds cloud software for life sciences

Veeva Systems builds cloud software and data products for pharmaceutical, biotechnology and other life sciences companies. Its applications support clinical trials, regulatory submissions, quality management, drug safety and commercial teams that work with healthcare professionals. Teams use the software to organize documents, track records and coordinate regulated work across departments on Veeva's Vault platform. Veeva earns revenue from subscriptions to its software and data products, alongside implementation, consulting and other professional services. Founded in 2007, Veeva Systems is headquartered in Pleasanton, California, United States.

Company size: 5,001-10,000
Company stage: IPO
Headquarters: Pleasanton, CA
Founded: 2007

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