GxP Project Manager

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

Job Summary

We are seeking an experienced GxP Project Manager / Consultant to lead and support Quality and Regulatory technology initiatives within the Life Sciences, Biotechnology, or pharmaceutical industry. The role will focus on Empower system upgrades, Veeva RIM Vault migrations, and other GxP-regulated system implementations and enhancements. The ideal candidate will collaborate with Quality, Regulatory, Validation, and IT teams to manage project planning, execution, compliance, and delivery while ensuring alignment with GxP requirements and organizational objectives.

Roles and Responsibilities

• Lead GxP-related projects from initiation and planning through execution, delivery, and closure.
• Develop and manage project plans, schedules, milestones, budgets, risks, issues, dependencies, and stakeholder communications.
• Coordinate Empower system upgrade activities, including validation planning, business requirements, testing, and implementation.
• Lead and support Veeva RIM Vault migrations and other regulatory and quality system initiatives.
• Collaborate with Quality Assurance, Regulatory Affairs, Validation, Laboratory, and IT teams to ensure successful project delivery.
• Support Quality Management System (QMS) processes, including CAPA, change control, deviation management, and regulatory compliance.
• Coordinate with technical writers and validation teams to ensure timely completion of project documentation and deliverables.
• Ensure project activities align with applicable GxP requirements and Computer System Validation (CSV) or Computer Software Assurance (CSA) methodologies.
• Facilitate project governance meetings, stakeholder reviews, and status reporting.
• Identify and mitigate project risks, resolve issues, and manage cross-functional dependencies.
• Support change management, system implementation, upgrade, migration, and continuous improvement activities.
• Coordinate onsite activities and occasional travel as required.

Education & Experience

• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Engineering, Information Technology, or a related field.
• PMP certification or equivalent project management certification is preferred.
• Minimum of 8+ years of experience in the Life Sciences, Biotechnology, or pharmaceutical industry.
• Proven experience managing projects in GxP-regulated environments.
• Strong project management experience leading Quality, Regulatory, and compliance-related technology initiatives.