Director - Computer Systems Validation

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. 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.

A minimum of 10+ years directly relevant experience in validation of enterprise software, computer information systems used in life sciences regulated environment (GMP, GCP, GLP, GvP)

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

Flexible PTO and company paid holidays

Retirement programs

1% charitable giving program

Compensation

Base pay: $130,000 - $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.