GxP Project Manager — Quality and Regulatory Technology

Job overview

The GxP Project Manager — Quality and Regulatory Technology role is onsite in Boston, MA. Compensation is not specified. The role supports Quality and Regulatory technology initiatives in life sciences, biotechnology, or pharmaceuticals. The project manager leads regulated system projects from planning through delivery, coordinating stakeholders, schedules, risks, budgets, validation, and documentation. The work helps ensure system upgrades and migrations meet GxP requirements and organizational objectives.

What you'll do

• Lead GxP projects from initiation through closure
• manage plans, schedules, milestones, budgets, risks, issues, dependencies, and communications
• coordinate Empower upgrades, validation planning, requirements, testing, and implementation
• lead or support Veeva RIM Vault migrations and other quality and regulatory system initiatives
• collaborate with Quality Assurance, Regulatory Affairs, Validation, Laboratory, and IT
• support QMS processes including CAPA, change control, and deviation management
• coordinate documentation
• align activities with GxP and CSV or CSA methodologies
• facilitate governance meetings and status reporting
• coordinate onsite activities and occasional travel as required.

What we're looking for

Skills & competencies

gxp project manager

quality technology

regulatory technology

life sciences

empower system upgrades

veeva rim vault

computer system validation

gxp compliance

boston ma

katalyst healthcares & life sciences

Work arrangement

• Weekend coverage required

Why this role

The posting requires at least eight years of life sciences, biotechnology, or pharmaceutical industry experience and proven GxP project management experience. A relevant bachelor’s degree is listed; PMP or equivalent certification is preferred.

About the employer

Katalyst Healthcares & Life Sciences is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.