Senior Manager, Veeva Regulatory & Data

Business Partnership & Solution Delivery

• Serve as a trusted technology partner to Quality, Clinical, Regulatory, and Safety stakeholders, developing a strong understanding of business priorities, processes, and evolving technology needs.
• Translate business and regulatory requirements into solution options, technical requirements, delivery plans, and measurable outcomes.
• Partner with the Senior Manager, Veeva Commercial and Data to execute the platform roadmap and align demand, priorities, dependencies, and delivery sequencing.
• Lead implementations, enhancements, integrations, releases, and continuous improvement initiatives across the GxP application portfolio.
• Communicate solution recommendations, delivery status, risks, dependencies, and tradeoffs clearly to business and technology stakeholders.
• Partner with business stakeholders to improve data quality, data stewardship, reporting enablement, and the effective use of application data supporting GxP business processes.
• Operate with a high degree of independence and judgment, making day-to-day application, technical, delivery, and operational decisions within established platform strategy and governance.

Application & Technical Leadership

• Provide technical leadership for Veeva and related GxP applications across solution design, configuration, integration, security, and lifecycle management.
• Design and configure complex Veeva Vault solutions when needed and maintain the technical depth required to troubleshoot issues, assess alternatives, and independently validate partner recommendations.
• Establish scalable configuration, integration, security, and release practices that improve consistency, maintainability, and supportability.
• Lead technical design for integrations between Veeva and adjacent applications, data platforms, identity services, middleware, APIs, and other regulated technologies.
• Partner with Cybersecurity, Data & Analytics, Infrastructure & Cloud, Quality, and Validation to ensure solutions align with enterprise standards and regulatory requirements.

Application Lifecycle & Operational Excellence

• Own the day-to-day health, performance, supportability, and service quality of assigned GxP applications.
• Ensure applications remain reliable, secure, compliant, scalable, and aligned with changing business requirements.
• Lead release planning, impact assessments, change execution, deployment readiness, and post-production support.
• Establish and monitor application health, service, delivery, quality, and adoption measures and use them to drive continuous improvement.
• Identify recurring issues, technical debt, lifecycle risks, and service gaps and drive appropriate remediation.
• Ensure effective incident, problem, change, enhancement, and escalation management across applications within scope.

Vendor & Delivery Management

• Lead managed service providers, systems integrators, consultants, and other external partners supporting the GxP application portfolio.
• Establish clear service, delivery, technical, and quality expectations and hold partners accountable for outcomes.
• Review and challenge vendor recommendations and technical solutions, ensuring decisions align with business requirements, architecture standards, and long-term application strategy.
• Manage delivery priorities, dependencies, escalations, risks, and performance across internal and external resources.
• Ensure effective documentation, knowledge transfer, operational readiness, and support transition for new and changed solutions.
• Build internal application knowledge and capability while using external partners strategically for capacity and specialized expertise.

GxP, Validation & Compliance

• Maintain the technical validated state of assigned applications and ensure changes remain appropriately controlled throughout the application lifecycle.
• Partner with Quality and Validation on validation strategy, impact assessment, testing, technical documentation, and remediation.
• Ensure solutions appropriately address applicable GxP requirements, electronic records and signatures, data integrity, access controls, audit trails, and regulated change requirements.
• Support regulatory inspections and audits and coordinate technical response and remediation for application-related observations.
• Promote practical, risk-based validation and compliance practices that support both regulatory expectations and sustainable technology delivery.

Knowledge & Skills

• Strong hands-on knowledge of Veeva Vault architecture, configuration, integrations, security, and application lifecycle management.
• Strong understanding of enterprise application delivery, operations, support, and service management.
• Demonstrated ability to translate business requirements into practical technology solutions and successfully lead those solutions through implementation and operation.
• Experience managing vendor-delivered technology services and providing technical oversight to systems integrators and managed service providers.
• Strong working knowledge of regulated GxP technology environments, computerized system validation, data integrity, and inspection-readiness expectations.
• Ability to independently assess complex business and technical issues, make sound decisions, resolve ambiguity, and engage specialized expertise when appropriate.
• Strong stakeholder management, communication, prioritization, problem-solving, and decision-making skills.
• Ability to balance business priorities, technical sustainability, regulatory requirements, operational risk, and delivery commitments.

Candidate Qualifications

• • Bachelor's degree or equivalent combination of education and relevant experience.
  • 8+ years of progressive experience in enterprise applications, technology delivery, application management, or related disciplines, preferably within pharmaceutical, biotechnology, or life sciences.
  • 4+ years of hands-on experience implementing, configuring, supporting, or delivering Veeva Vault solutions across Quality, Clinical, Regulatory, Safety, or related regulated functions.
  • Experience across Veeva Vault applications supporting Quality, Clinical, Regulatory, and Safety, such as QualityDocs, QMS, Training, Clinical Operations, RIM, and Safety.
  • Experience leading implementations, enhancements, integrations, releases, and operational support for enterprise applications in validated GxP environments.
  • Experience managing technology delivery involving managed service providers, systems integrators, consultants, or vendor-delivered solutions.
  • Experience serving as a platform owner, technical lead, solution delivery lead, or comparable technology leadership role supporting regulated applications.
  • Experience establishing trusted relationships with business stakeholders and translating complex business and regulatory needs into technology outcomes.
  • Demonstrated ability to independently assess complex business and technical issues, make sound decisions, resolve ambiguity, and drive solutions through implementation and ongoing operation.
  • Working knowledge of pharmaceutical regulatory requirements as applied to technology, including 21 CFR Part 11, computerized system validation, data integrity, and inspection readiness.
  • Veeva Vault certification or advanced experience across multiple Veeva applications.
  • Deep familiarity with the Veeva ecosystem (Vault, Network) and its data integration patterns.
  • Experience leading application delivery teams, platform teams.
  • Experience supporting data quality, data stewardship, reporting enablement, or data governance initiatives within regulated environments.
  • Experience applying CSA principles and risk-based validation approaches.
  • Experience integrating Veeva with ERP, data and analytics, middleware, identity, clinical, regulatory, or quality platforms; SAP experience is a plus.
  • Prior experience in rare disease, specialty pharma, or biotechnology supporting regulated R&D and Quality operations.
  • Experience supporting late-stage clinical development, commercialization readiness, and the growth of global regulated operations within a biotechnology or pharmaceutical organization.
  • ITIL, Product Management, Agile, Project Management, or related certifications preferred.