Project Manager Regulated Systems (Veeva Implementation)

Job Title: Project Manager Regulated Systems (Veeva Implementation)

Position Summary

We are seeking an experienced Project Manager with a strong background in regulated systems and vendor/IT coordination to lead the implementation and enhancement of Veeva applications (Vault QMS, RIM, QualityDocs, etc.). The ideal candidate will have demonstrated success managing projects in GxP-regulated environments, ensuring compliance, alignment with business objectives, and timely delivery of system solutions.

Key Responsibilities

• Lead end-to-end project management for Veeva system implementations, upgrades, and integrations within a regulated (GxP) environment.
• Develop and manage project plans, timelines, budgets, and resource allocations.
• Coordinate and communicate across internal IT teams, business stakeholders, and external vendors/partners to ensure project success.
• Oversee project governance, risk management, and change control processes.
• Ensure deliverables meet compliance requirements (e.g., 21 CFR Part 11, Annex 11, GAMP 5).
• Facilitate user requirements gathering, system design reviews, validation planning, and testing activities.
• Track and report project progress to leadership through regular status updates, dashboards, and executive summaries.
• Support training, change management, and post-implementation adoption efforts.
• Manage vendor relationships, ensuring adherence to contracts, SLAs, and quality standards.

Qualifications

Required:

• Bachelor's degree in Computer Science, Information Systems, Engineering, or a related field.
• 5+ years of project management experience, preferably in the life sciences or pharmaceutical industry.
• Proven experience implementing or managing Veeva Vault applications (e.g., QualityDocs, QMS, RIM, eTMF).
• Strong understanding of GxP, CSV (Computer System Validation), and regulatory compliance.
• Demonstrated ability to manage cross-functional teams and third-party vendors.
• Excellent communication, organizational, and stakeholder management skills.
• Proficiency with project management tools (e.g., MS Project, Smartsheet, Jira, Asana).

Preferred:

• PMP, PRINCE2, or Agile certification.
• Experience with cloud-based SaaS systems in a validated environment.
• Familiarity with SDLC, Agile, and hybrid project methodologies.
• Experience working in a biotech, pharma, or medical device organization.