Project Manager Regulated Systems (Veeva Implementation)

Project Manager Regulated Systems (Veeva Implementation)

Posted Today by 1763549212

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Negotiable
Outside
Remote
USA
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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: We are looking for a Project Manager with expertise in regulated systems and vendor/IT coordination to oversee the implementation of Veeva applications in a GxP-regulated environment. The role requires managing project timelines, budgets, and resources while ensuring compliance with regulatory standards. The ideal candidate will have a proven track record in project management within the life sciences or pharmaceutical industry. Strong communication and organizational skills are 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: USA

Working Arrangements: remote

IR35 Status: outside IR35

Seniority Level: undetermined

Industry: Other

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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