Quality/Validation Project Manager

Introduction

The Validation / Quality Project Manager is a key member of the PMO. This role is responsible for ensuring that validation strategy, quality oversight, and GxP compliance requirements are properly integrated across multiple concurrent system implementations. The individual will not execute validation protocols directly but will oversee validation planning, vendor deliverables, and ensure that regulatory expectations are incorporated into overall project execution.

Responsibilities

• Validation Strategy & Oversight
  • Ensure validation requirements are properly defined and incorporated into project plans.
  • Oversee validation lifecycle activities including:
    • Validation planning
    • Risk assessments
    • Protocol development oversight (IQ/OQ/PQ where applicable)
    • Traceability matrix alignment
    • Validation summary reporting
  • Confirm validation deliverables are aligned with corporate quality standards and regulatory expectations.
• GxP Compliance Integration
  • Ensure that GxP considerations are embedded throughout system implementations.
  • Partner with Quality, CSV, and IT teams to ensure compliance alignment.
  • Review system impact assessments and validation classifications.
  • Validate that change control processes are properly followed.
• Vendor & Third-Party Oversight
  • Review third-party vendor validation documentation for completeness and regulatory alignment.
  • Ensure vendors account for:
    • Data migration validation
    • Data integrity controls
    • System configuration traceability
    • Interface validation
  • Identify gaps in vendor validation plans and escalate as needed.

Requirements

Required Qualifications

• 5+ years of experience overseeing validation, quality, or CSV within a regulated pharmaceutical/biotech environment.
• Strong understanding of GxP regulations and validation lifecycle.
• Experience overseeing validation activities for enterprise IT systems.
• Experience with system implementations (ERP, QMS, MES, LIMS, etc.).
• Familiarity with data integrity and data migration validation.
• Experience reviewing vendor validation documentation.
• Strong understanding of SDLC and how validation integrates into project execution.
• Excellent documentation review and analytical skills.

Education

• Bachelor''s degree in Engineering, Life Sciences, or related technical field