Cell Therapy Change Control Project Lead

Biopharma-Consulting-Jad-Group; Boston (MA); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Overtime availability

Job summary

The Change Control Project Manager role at Biopharma-Consulting-Jad-Group coordinates cross-functional teams to manage change controls for cell and gene therapy projects in Boston. You will maintain integrated project plans, track milestones, and drive timely decisions in a GMP environment.

You will communicate status to stakeholders, organize team communications, and develop tools to support change control activities while adhering to SOPs and regulatory requirements (FDA, EU GMP, ICH Q10).

Qualifications

• Bachelor’s degree in engineering, life sciences or related field.
• 8+ years in biopharmaceutical industry.
• 6+ years in project management of biopharmaceutical products.
• Knowledge of GMPs, regulatory requirements and drug development lifecycle.
• Ability to manage multiple tasks in a cross-functional environment.
• Proficiency with MS Office and PM tools (Smartsheet, Power BI).
• Strong written and oral communication, facilitation and presentation skills.

Responsibilities

• Partner with functional area leads to maintain and monitor integrated project plans.
• Track milestones and critical path activities to drive changes to completion.
• Communicate status, risks and mitigation plans to stakeholders.
• Organize team communications, agendas, minutes, tasks, and risk analyses.
• Update project status tools and risk registers.
• Develop and deliver PM templates and tools for the change control team.
• Comply with SOPs and applicable GxP requirements.

Skills

Project management

Cross-functional collaboration

Communication

Analytical thinking

Problem solving

Education

Bachelor's degree in engineering or life sciences

Tools

MS Project

PowerPoint

SharePoint

Word

Excel

Outlook

Smartsheet

Power BI

Job description

The Change Control Project Manager role at Biopharma-Consulting-Jad-Group coordinates cross-functional teams to manage change controls for cell and gene therapy projects in Boston. You will maintain integrated project plans, track milestones, and drive timely decisions in a GMP environment.

You will communicate status to stakeholders, organize team communications, and develop tools to support change control activities while adhering to SOPs and regulatory requirements (FDA, EU GMP, ICH Q10).