Role Summary The Director, Veeva Architecture & Implementations is the accountable technical and delivery leader for the company's Veeva ecosystem as it scales from clinical development toward regulatory submission and commercial readiness. This role owns the multi-year Veeva roadmap, defines the target-state architecture across the Vault platform, and leads phased implementations with business owners and implementation partners.
Because the company is building many of its systems for the first time, the ideal candidate is a hands-on, player-coach architect who can set strong foundations early: a well-governed Vault configuration, validated and audit-ready processes, clean integrations, and an operating model that scales as the pipeline matures.
Key Responsibilities Veeva Strategy & Architecture - Own the enterprise Veeva roadmap and target-state architecture across Vault Clinical (eTMF, CTMS, Study Startup), Vault Quality (QMS, QualityDocs, Training), Vault RIM (Registrations, Submissions, Publishing), Vault Safety, and, as the company approaches launch, Vault PromoMats/MedComms and Vault CRM.
- Define platform standards for multi-Vault design, object and lifecycle configuration, security and sharing models, data model governance, and cross-Vault connections.
- Sequence Vault deployments against clinical, regulatory, and quality milestones, balancing out-of-the-box adoption against configuration needs to minimize technical debt.
Implementation Leadership - Lead end-to-end Vault implementations from requirements and solution design through configuration, data migration, testing, cutover, and hypercare.
- Select, contract, and direct Veeva Professional Services and third-party implementation partners; manage scope, schedule, budget, and quality of partner deliverables.
- Facilitate design workshops with Clinical Operations, Quality, Regulatory Affairs, Pharmacovigilance, and Commercial stakeholders, translating business processes into fit-for-purpose Vault solutions.
- Plan and oversee migrations from legacy or file-share-based processes and CRO-hosted systems into company-owned Vaults.
Integration & Data - Design integrations between Veeva and enterprise systems (e.g., EDC, IRT, ERP, HRIS/LMS, safety databases, and data platforms) using Vault APIs, the Vault Java SDK, Spark messaging, Vault Loader, and middleware.
- Establish master data, reference data, and document metadata standards that support inspection readiness and downstream analytics.
Validation, Compliance & Release Management - Ensure Veeva systems are implemented and maintained in a validated state consistent with GxP, 21 CFR Part 11, EU Annex 11, and a risk-based CSV/CSA approach, in partnership with Quality.
- Own the Veeva release management process for the three annual general releases: impact assessment, regression testing, change control, and business readiness communications.
- Support audits and regulatory inspections as the system owner or technical SME for Veeva applications.
Governance, Team & Vendor Management - Stand up the Veeva Center of Excellence: governance forums, intake and prioritization, configuration standards, and administrator enablement.
- Build and mentor a lean team of Vault administrators and business analysts, augmenting with contract resources as needed; manage Veeva licensing, renewals, and the platform budget.
Required Qualifications - Bachelor's degree in Information Systems, Computer Science, Life Sciences, or a related field.
- 10+ years of life sciences IT experience, with 6+ years architecting and implementing Veeva Vault applications across at least two domains (Clinical, Quality, RIM, or Safety).
- Proven track record leading multiple full-lifecycle Vault implementations, including partner management and data migration.
- Deep working knowledge of Vault configuration, lifecycles, workflows, security models, Vault connections, and the Vault API.
- Strong command of GxP computerized system validation, 21 CFR Part 11, EU Annex 11, and change control in a regulated environment.
- Experience defining technical roadmaps and presenting recommendations to executive leadership.
Preferred Qualifications - Veeva Vault certifications (e.g., Vault Platform Administrator, application-specific certifications).
- Experience in an emerging or pre-commercial biopharma company, including first-time system build-outs and launch readiness.
- Exposure to Vault CRM, PromoMats, or MedComms, including commercial readiness and MLR process design.
- Familiarity with eCTD submissions, IDMP, and TMF Reference Model standards; PMP or Agile certification.
All candidates must have direct professional experience within the Life Sciences industry, specifically pharmaceutical, biotechnology, biopharmaceutical, or therapeutics organizations. Experience limited to general healthcare, hospitals/health systems, payers, providers, or healthcare technology
does not meet this requirement.
Key Competencies - Architectural Judgment: Makes sound platform decisions that hold up as the organization scales.
- Hands-On Leadership: Comfortable configuring a Vault one day and briefing executives the next.
- Stakeholder Partnership: Builds trust with Clinical, Quality, Regulatory, and Commercial leaders and bridges business and technical teams.
- Compliance Mindset: Treats validation and inspection readiness as design requirements, not afterthoughts.
- Vendor Management: Holds partners accountable for quality, schedule, and cost.
Work Environment Hybrid role with periodic on-site presence in Hampton, NJ for workshops, go-lives, and audits. Occasional travel (up to 10%) and flexibility around key release and cutover windows may be required.
Contract Length: 6• 12+ month contract, with potential for extension
This job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described, and may be amended at any time at the sole discretion of the Employer
