GxP Project Manager/Consultant

About the role

Lead Quality and Regulatory technology initiatives within the life sciences and pharmaceutical industries.

Tasks

• Lead GxP projects from initiation and planning through execution, delivery, and closure.
• Develop and manage project plans, schedules, milestones, budgets, risks, issues, and dependencies.
• Coordinate Empower system upgrades, including business requirements, validation planning, 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.

Requirements

• 8+ years of experience in the life sciences, biotechnology, or pharmaceutical industry.
• Proven experience managing projects in GxP-regulated environments.
• Strong project management experience with Quality, Regulatory, and compliance-related technology initiatives.
• Knowledge of GxP compliance, CSV/CSA methodologies, and quality system processes.
• Strong stakeholder management, communication, risk management, and project planning skills.
• Preferred: Project Management Professional (PMP) certification or equivalent project management certification.
• Preferred: Experience with Empower upgrades, Veeva RIM Vault migrations, and regulated system implementations.
• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Engineering, Information Technology, or a related field.

How to apply

• Connect with us or send your resume.

Location

• Boston, MA, Katalyst Pro.