Technical Project Manager – Life Sciences (Consultant)

Role Overview

ViaPoint is seeking an experienced Technical Project Manager – Life Sciences (Consultant) to support a portfolio of Clinical, Medical, Regulatory, Quality, and R&D initiatives within a large-scale enterprise transformation program. The role is highly execution-focused and spans the Project Management Lifecycle (PMLC) and System Development Lifecycle (SDLC) with a strong emphasis on regulated environments (GxP, CSV).

Responsibilities

• Lead end-to-end delivery across PMLC/SDLC phases, including:
  • Strategy & planning
  • Requirements gathering (URS/FRS)
  • Architecture & design
  • Build/configuration & integration
  • Data migration
  • Testing (Unit, SIT, UAT)
  • Validation (IQ, OQ, PQ)
  • Deployment, cutover, and hypercare
• Drive execution for validated platforms and applications (e.g., QMS, CTMS, LIMS, RIMS, and related regulated systems)
• Establish and manage hybrid delivery models (Agile + Waterfall) based on scope and regulatory needs
• Build and maintain integrated project plans including:
  • RAID logs
  • Financial tracking
  • Executive reporting
• Coordinate cross-functional stakeholders across IT, Quality/Validation, Regulatory, Clinical, and external vendors
• Ensure alignment with GxP, CSV, and compliance standards, including:
  • Documentation and traceability (RTM)
  • Audit readiness
• Coordinate vendor deliverables (hosting, implementation, validation artifacts) to ensure quality and timeliness
• Identify, mitigate, and drive decisions on risks in fast-paced, high-visibility environments
• Support program governance (e.g., steering committees and executive communications)

Required Qualifications

• 8+ years of experience in project/program management with strong exposure to technical delivery and system implementations
• 3+ years in life sciences or other regulated environments (GxP, CSV)
• Proven delivery across full SDLC and validation lifecycles, including testing and qualification (IQ/OQ/PQ)
• Hands-on experience with enterprise applications, data migration, and system integrations
• Experience operating in hybrid Agile/Waterfall environments
• Strong familiarity with validation deliverables (URS, FRS, RTM, test scripts, validation plans/reports)
• Exceptional stakeholder management skills, including executive leadership and global teams
• Ability to operate in high-pressure, deadline-driven environments with multiple concurrent workstreams

Preferred Qualifications

• Certifications such as PMP, PRINCE2, CSM, SAFe (or equivalent)
• Experience with Quality, Clinical, Medical, or Regulatory systems (e.g., QMS, CTMS, LIMS, RIMS)
• Background in M&A integrations or large-scale transformation programs
• Experience coordinating vendor-led implementations and managed services
• Familiarity with tools such as Smartsheet, Jira, Azure DevOps (or similar)