Senior Project Manager -GxP Validation - Compunnel : Job Details

Senior Project Manager -GxP Validation

Compunnel

Job Location : Mahwah,NJ, USA

Posted on : 2025-08-08T01:06:43Z

Job Description :

Job Summary:We are seeking a Sr IT Project Manager with strong experience in cloud-based solutions and regulatory compliance to support one of our global Healthcare Devices/Life Science clients. This role focuses on managing cloud-based implementation projects, with an emphasis on GxP validation and regulatory compliance. The successful candidate will work collaboratively with various cross-functional teams, manage project scope, budget, and schedule, and deliver cost-effective implementations that meet stakeholder expectations.

Key Responsibilities:• Lead the detailed planning and management of projects from inception to completion.• Understand Validation, Transparency Laws, and integration of Healthcare/Pharma systems with legacy systems.• Oversee projects involving validated systems and computer system validation nuances.• Manage large projects with multiple IT teams and systems, focusing on GxP validation processes.• Communicate and present to stakeholders, ensuring project success and alignment.• Manage scope, budget, and schedule for projects, ensuring they meet success criteria.• Create and maintain project-related documents like charters, plans, risk registers, issue lists, and presentations.• Establish and maintain project information in the PPM tool.• Develop comprehensive project plans and ensure adherence to change control processes.• Lead cross-functional team meetings, ensuring capture of action items and discussion points.• Work with business managers to propose and implement technology-based improvements.• Ensure project milestones are met and manage resources, risks, and issues to ensure timely delivery.

Required Qualifications:• Minimum of 15 years of experience as an IT project manager.• At least 5+ years of experience in the Pharma/Healthcare industry (e.g., Biotech, Pharma, Medical Equipment).• Bachelor's degree in computer science or a relevant field.• 5+ years of experience in cloud-based solution implementations.• Certified in PMP, Agile, or Scrum frameworks.

Preferred Qualifications:• Experience implementing Healthcare/Pharma system cloud integrations.• Strong understanding of cloud-based solutions and life sciences industry.• Knowledge of GxP, Transparency Laws, and Validation processes.• Strong project management skills with experience in vendor management, risk, issue, and performance management.• Strong soft skills and excellent communication (verbal, written, and presentation).• Familiarity with Planview is a plus.• Agile/Scrum project experience.

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