Project Manager Regulated Systems (Veeva Implementation)

Project Manager Regulated Systems (Veeva Implementation)

Posted Today by Arnex Solutions LLC

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Negotiable
Undetermined
Remote
Remote
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Agile Methodology Asana Change Management Computer Science Computer Systems Computer System Validation Information Systems JIRA Management Preparing Executive Summaries Project Governance Project Management Requirements Elicitation Risk Management Smartsheet Software as a Service (SaaS) Stakeholder Management Systems Design Verification And Validation

Summary: The Project Manager for Regulated Systems will lead the implementation and enhancement of Veeva applications within GxP-regulated environments. This role requires a strong background in project management, vendor coordination, and compliance to ensure timely delivery of system solutions. The ideal candidate will have a proven track record in managing projects that align with business objectives while adhering to regulatory standards. Experience in the life sciences or pharmaceutical industry is essential for success in this position.

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.

Key Skills:

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

Salary (Rate): undetermined

City: undetermined

Country: undetermined

Working Arrangements: remote

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other

Detailed Description From Employer:

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.
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