GxP RegTech Project Lead

Katalyst-Healthcares-; Boston (MA); On-site; USD 120,000 - 160,000; Full time

Job summary

Katalyst-Healthcares- is seeking an experienced GxP Project Manager / Consultant to lead and support Quality and Regulatory technology initiatives within Life Sciences, Biotechnology, or pharmaceutical industries. The role focuses on Empower system upgrades, Veeva RIM Vault migrations, and other GxP-regulated system implementations and enhancements.

You will collaborate with Quality, Regulatory, Validation, Laboratory, and IT teams to manage project planning, execution, and compliance while

Qualifications

• 8+ years in Life Sciences/pharma with GxP exposure.
• Experience leading Quality, Regulatory, and compliance tech initiatives.
• PMP or equivalent certification preferred.

Responsibilities

• Lead GxP-related projects from initiation to closure.
• Develop and manage project plans, schedules, budgets, risks, issues, dependencies, and stakeholder communications.
• Coordinate Empower upgrades including validation and requirements.
• Lead Veeva RIM Vault migrations and related initiatives.
• Collaborate with QA, Regulatory Affairs, Validation, Lab, and IT.
• Ensure CSV/CSA compliance and timely documentation.

Skills

GxP compliance

Project management

Regulatory technology

PMP certification

Budget & risk management

CSV/CSA methodologies

Education

Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Engineering, IT

Tools

Empower system

Veeva RIM Vault

Job description

Katalyst-Healthcares- is seeking an experienced GxP Project Manager / Consultant to lead and support Quality and Regulatory technology initiatives within Life Sciences, Biotechnology, or pharmaceutical industries. The role focuses on Empower system upgrades, Veeva RIM Vault migrations, and other GxP-regulated system implementations and enhancements.

You will collaborate with Quality, Regulatory, Validation, Laboratory, and IT teams to manage project planning, execution, and compliance while